protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT03693300 | 6.4.3 | Rescue medication | As a result of imAEs that could potentially be experienced by patients on durvalumab (MEDI4736), steroids and other immunosuppressant rescue medication have to be made available to this patient population. The 2 products that fall into the category of immunosuppressants are infliximab (eg, for colitis) and mycophenolat... | [] |
NCT03693300 | 6.5 | Dose modification | Dose delays are permitted for the management of certain IP-related toxicities as described in the Dosing Modification and Toxicity Management Guidelines (see Section 8.4.5.1 and Dosing Modification and Toxicity Management Guidelines in the Annex document to this CSP). Dose reductions are not permitted. | [] |
NCT03693300 | 6.6 | Treatment after the end of the study | After the final analysis, AstraZeneca will continue to supply the IP to patients up to the time that they discontinue the treatment for whatever reason (see Section 6.1.3). | [] |
NCT03693300 | 7 | DISCONTINUATION OF TREATMENT AND SUBJECT WITHDRAWAL | [] | |
NCT03693300 | 7.1 | Discontinuation of study drug | An individual patient will not receive any further IP if any of the following occur in the patient in question:
- Withdrawal of consent from further treatment with IP. The patient is, at any time, free to discontinue treatment, without prejudice to further treatment. Patient who discontinue treatment are normally expe... | [] |
NCT03693300 | 7.1.1 | Procedures for discontinuation of study drug | Discontinuation of study drug, for any reason, does not impact the patient's participation in the study. A patient who decides to discontinue IP will always be asked about the reason(s) for discontinuation and the presence of any AE. The patient should continue attending subsequent study visits, and data collection sho... | [] |
NCT03693300 | 7.2 | Lost to follow-up | Patients will be considered lost to follow-up only if no contact has been established by the time the study is completed (see Section 4.4), such that there is insufficient information to determine the patient's survival status at that time. Patients who refuse to continue participation in the study, including telephone... | [] |
NCT03693300 | 7.3 | Withdrawal from the study | Patients are free to withdraw from the study at any time (IP and assessments) without prejudice to further treatment.
Patients who withdraw consent for further participation in the study will not receive any further IP or further study observation, with the exception of follow-up for survival, which will continue unti... | [] |
NCT03693300 | 8 | STUDY ASSESSMENTS AND PROCEDURES | Study procedures and their timing are summarized in Table 1 and Table 2.
A Web-Based Data Capture (WBDC) system will be used for data collection and query handling. The Investigator will ensure that data are recorded on the eCRF as specified in the study protocol and in accordance with the instructions provided.
The ... | [] |
NCT03693300 | 8.1 | Efficacy assessments | The key efficacy endpoints are: median PFS; proportion of patients progression-free at 12 months (PFS12) and 24 months (PFS24); median OS; proportion of patients alive at 12 months (OS12), 24 months (OS24), and 36 months (OS36), respectively; and median time to NSCLC-related death, from first IP dose administration; OR... | [] |
NCT03693300 | 8.1.1 | Survival assessments | Assessments for survival must be made q12w (±2 weeks) following treatment discontinuation. Survival information may be obtained via telephone contact with the patient or the patient's family or by contact with the patient's current physician. The details of first and subsequent therapies for cancer, after discontinuati... | [] |
NCT03693300 | 8.1.2 | Patient-reported outcome assessments | 'Patient-reported outcomes' is an umbrella term referring to any report of the status of a patient's health condition that comes directly from the patient, without interpretation of anyone else. PROs have become a significant endpoint when evaluating effectiveness of treatments in clinical studies. The following PRO qu... | [] |
NCT03693300 | 8.1.2.4 | Administration of patient-reported outcome questionnaires | Patients will perform the PRO assessments using an electronic tablet (ePRO) during clinic visits and will take approximately 15 minutes to complete.
Each centre must allocate the responsibility for the administration of the PRO instruments to a specific individual (eg, a research nurse or study coordinator) and, if po... | [] |
NCT03693300 | 8.1.2.5 | Calculation or derivation of patient-reported outcome variables | 
 | [] |
NCT03693300 | 8.2 | Safety assessments | Planned timepoints for all safety assessments are provided in Table 1 and Table 2. | [] |
NCT03693300 | 8.2.1 | Clinical safety laboratory assessments | Blood and urine samples for determination of clinical chemistry, haematology, and urinalysis will be taken at the times indicated in the assessment schedules and as clinically indicated (see Table 1 and Table 2).
Clinical laboratory safety tests, including serum pregnancy tests, will be performed in a licensed clinica... | [] |
NCT03693300 | 8.2.2 | Physical examinations | Physical examinations will be performed according to the assessment schedules (see Table 1 and Table 2). Full physical examinations will include assessments of the head, eyes, ears, nose, and throat and the respiratory, cardiovascular, GI, urogenital, musculoskeletal, neurological, dermatological, haematologic/lymphati... | [] |
NCT03693300 | 8.2.3 | Vital signs | Vital signs (blood pressure [BP], pulse, temperature, and respiratory rate) will be evaluated according to the assessment schedules (see Table 1 and Table 2). Body weight is also recorded at each visit along with vital signs. The following timepoints for vital signs assessments apply to infusions of durvalumab (MEDI473... | [
"First IP dose administration",
"Subsequent IP dose administrations",
"Pneumonitis (Interstitial lung disease) investigation"
] |
NCT03693300 | 8.3 | Collection of adverse events | The Investigator is responsible for ensuring that all staff involved in the study are familiar with the content of this Section.
The definitions of an AE and SAE can be found in Appendix B.
AE will be reported by the patient (or, when appropriate, by a caregiver, surrogate, or the patient's legally authorised represe... | [] |
NCT03693300 | 8.3.1 | Method of detecting adverse events and serious adverse events | Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and non-leading verbal questioning of the patient is the preferred method to inquire about AE occurrences. | [] |
NCT03693300 | 8.3.2 | Time period and frequency for collecting adverse event and serious adverse event information | AEs and SAEs will be collected from time of signature of informed consent throughout the treatment period and including the follow-up period (90 days after the last dose of IP). If an event that starts post the defined safety follow-up period noted above is considered to be due to a late-onset toxicity to study drug th... | [] |
NCT03693300 | 8.3.3 | Follow-up of adverse events and serious adverse events | During the course of the study, all AEs and SAEs should be proactively followed up for each patient. Every effort should be made to obtain a resolution for all events, even if the events continue after discontinuation or study completion.
Any AEs that are unresolved at the patient's last visit in the study are followe... | [] |
NCT03693300 | 8.3.4 | Adverse event data collection | The following variables will be collected for each AE:
- AE (verbatim)
- The date when the AE started and stopped
- The maximum CTCAE Grade reported
- Changes in CTCAE Grade (report only the maximum CTCAE Grade for the calendar day)
- Whether the AE is serious or not
- Investigator causality rating against the IPs (y... | [] |
NCT03693300 | 8.3.5 | Causality collection | The Investigator will assess causal relationship between IP and each AE, and answer "yes" or "no" to the question "Do you consider that there is a reasonable possibility that the event may have been caused by the investigational product?"
For SAEs, causal relationship will also be assessed for other medication and stu... | [] |
NCT03693300 | 8.3.6 | Adverse events based on signs and symptoms | All AEs spontaneously reported by the patient or reported in response to the open question from the study site staff, "Have you had any health problems since the previous visit/you were last asked?", or revealed by observation will be collected and recorded in the eCRF. When collecting AEs, the recording of diagnoses i... | [] |
NCT03693300 | 8.3.7 | Adverse events based on examinations and tests | The results from the protocol-mandated laboratory tests and vital signs will be summarized in the CSR. Deterioration as compared to baseline in protocol-mandated laboratory values and vital signs should therefore only be reported as AEs if they fulfil any of the SAE criteria or are the reason for discontinuation of tre... | [] |
NCT03693300 | 8.3.8 | Hy's law | Cases where a patient shows elevations in liver biochemistry may require further evaluation and occurrences of AST or ALT ≥3 × ULN together with total bilirubin ≥2 × ULN may need to be reported as SAEs. Please refer to Appendix E for further instruction on cases of increases in liver biochemistry and evaluation of HL. | [] |
NCT03693300 | 8.3.9 | Disease progression | Disease progression can be considered as a worsening of a patient's condition attributable to the disease for which the IP is being studied. It may be an increase in the severity of the disease under study and/or increases in the symptoms of the disease. The development of new or progression of existing metastasis to t... | [] |
NCT03693300 | 8.3.10 | New cancers | The development of a new cancer should be regarded as an SAE. New primary cancers are those that are not the primary reason for the administration of the IP and have been identified after the patient's inclusion in this study. | [] |
NCT03693300 | 8.3.11 | Deaths | All deaths that occur during the study treatment period or within the protocol-defined follow-up period after the administration of the last dose of IP must be reported as follows:
- Death clearly the result of disease progression should be reported to the Study Monitor/Physician at the next monitoring visit and shoul... | [] |
NCT03693300 | 8.3.12 | Adverse events of special interest | An AESI is one of scientific and medical interest specific to understanding of the IP and may require close monitoring and rapid communication by the Investigator to the Sponsor. An AESI may be serious or non-serious. The rapid reporting of AESIs allows ongoing surveillance of these events in order to characterize and ... | [] |
NCT03693300 | 8.3.13 | Safety data to be collected following the final data cut-off of the study | For patients continuing to receive IP treatment after final DCO and database closure, it is recommended that the patients continue the scheduled site visits and Investigators monitor the patient's safety laboratory results prior to and periodically during treatment with IP in order to manage AEs in accordance with the ... | [] |
NCT03693300 | 8.4 | Safety reporting and medical management | [] | |
NCT03693300 | 8.4.1 | Reporting of serious adverse events | All SAEs have to be reported, whether or not considered causally related to the IP or to the study procedure(s). All SAEs will be recorded in the eCRF.
If any SAE occurs in the course of the study, then Investigators or other site personnel inform the appropriate AstraZeneca representatives within 1 day, ie, immediate... | [] |
NCT03693300 | 8.4.2 | Pregnancy | All pregnancies and outcomes of pregnancy should be reported to AstraZeneca except for pregnancy discovered before the study patient has received any IP. | [] |
NCT03693300 | 8.4.2.1 | Maternal exposure | If a patient becomes pregnant during the course of the study, the IP should be discontinued immediately.
Pregnancy itself is not regarded as an AE unless there is a suspicion that the IP under study may have interfered with the effectiveness of a contraceptive medication. Congenital abnormalities or birth defects and ... | [] |
NCT03693300 | 8.4.2.2 | Paternal exposure | Male patients should refrain from fathering a child or donating sperm during the study and for 90 days following the last dose of IP.
Pregnancy of the patient's partners is not considered to be an AE. However, the outcome of all pregnancies (spontaneous miscarriage, elective termination, ectopic pregnancy, normal birt... | [] |
NCT03693300 | 8.4.3 | Overdose | Use of durvalumab (MEDI4736) in doses in excess of that specified in the protocol is considered to be an overdose. There is currently no specific treatment in the event of overdose of durvalumab (MEDI4736), and possible symptoms of overdose are not established.
- An overdose with associated AEs is recorded as the AE d... | [] |
NCT03693300 | 8.4.4 | Medication error | If a medication error occurs in the course of the study, then the Investigator or other site personnel informs the appropriate AstraZeneca representatives within 1 day (ie, immediately but no later than 24 hours) of when he or she becomes aware of it.
The designated AstraZeneca representative works with the Investigat... | [] |
NCT03693300 | 8.4.5 | Management of investigational product-related toxicities | The following general guidance should be followed for management of toxicities:
- Treat each of the toxicities with maximum supportive care (including holding the agent suspected of causing the toxicity if required).
- If the symptoms promptly resolve with supportive care, consideration should be given to continuing t... | [] |
NCT03693300 | 8.4.5.1 | Specific toxicity management and dose modification information – Durvalumab and durvalumab + tremelimumab | Comprehensive toxicity management guidelines (TMGs) have been developed to assist investigators with the recognition and management of toxicities associated with use of the immune-checkpoint inhibitors, durvalumab [MED4736] (PD-L1 inhibitor) and tremelimumab (CTLA-4 inhibitor). Given the similar underlying mechanism of... | [] |
NCT03693300 | 8.5 | Pharmacokinetics | PK parameters are not evaluated in this study. | [] |
NCT03693300 | 8.6 | Pharmacodynamics | PDx parameters are not evaluated in this study.
 | [] |
NCT03693300 | 8.9 | Health economics | Health economic parameters are not evaluated in this study. | [] |
NCT03693300 | 9 | STATISTICAL CONSIDERATIONS | [] | |
NCT03693300 | 9.1 | Statistical hypotheses | No formal statistical hypothesis will be tested in this study. | [] |
NCT03693300 | 9.2 | Sample size determination | The primary objective of this study is to assess the safety and tolerability of durvalumab (MEDI4736) which is defined as Grade 3 and Grade 4 TRAEs observed within 6 months after the initiation of durvalumab (MEDI4736) treatment. In addition, safety and tolerability of durvalumab (MEDI4736) will be characterized for th... | [] |
NCT03693300 | 9.3 | Populations for analyses | All analyses will be performed on the safety analysis set. | [] |
NCT03693300 | 9.3.1 | Safety analysis set | The safety analysis set will consist of all patients who received at least 1 dose of IP. Safety and efficacy data will be summarized using the safety analysis set. | [] |
NCT03693300 | 9.4 | Outcome measures for analyses | - 1 AE: Number and proportion of patients with AEs in total and by causality and severity
- 2 AE: Number and proportion of patients with Grade 3 and Grade 4 AEs
- 3 SAE: Number and proportion of patients with SAEs in total and by causality and severity
- 4 AEs leading to death: Number and proportion of patients with AE... | [] |
NCT03693300 | 9.5.2 | Analysis of the secondary variables | [] | |
NCT03693300 | 9.5.2.1 | Safety variables |
Total SAEs, AESIs, AEs leading to death, and AEs leading to study drug interruption or discontinuation will be summarized by Medical Dictionary for Regulatory Activities (MedDRA) by system organ class and preferred term, causality and maximum NCI CTCAE Grade. Deaths from all causes will be also summarized.
Data from... | [
"Safety variables – adverse events"
] |
NCT03693300 | 9.5.2.2 | Efficacy variables | Efficacy data will be reported for patients overall and separately for the cohorts of WHO/ECOG PS 0 to 1 and 2 patients whenever possible.
The median PFS together with the corresponding 95% CIs will be reported using Kaplan-Meier product limit methods. In addition, the proportion of patients who are progression-free a... | [
"Progression-free survival",
"Overall survival",
"Lung cancer mortality (NSCLC-related deaths)",
"Objective response rate"
] |
NCT03693300 | 9.5.2.3 | Patient-reported outcomes | 
Summaries for endpoints of interest by subgroup will be detailed in the SAP. | [
"Subgroup analysis"
] |
NCT03693300 | 9.6 | Interim analysis | No formal interim analysis is planned for this study. However, the SC will conduct an early safety evaluation when 10 patients in the WHO/ECOG PS 2 cohort have been treated for a minimum of 6 months or discontinued due to an AE or disease progression, whichever occurs first. At the time of the early safety evaluation, ... | [] |
NCT03693300 | 9.6.1 | Steering committee | A SC will be assembled by AstraZeneca for the executive oversight and supervision of the study. The SC will consist of oncology experts and a statistician who serve their role through regular scheduled meetings or teleconferences and, if necessary, additional ad hoc meetings.
Details of the SC remit, procedures, proce... | [] |
NCT03693300 | 9.7 | Data management by AstraZeneca or delegate | Data management will be performed by a Contract Research Organisation according to the Data Management Plan.
Any data collected through third party sources will be obtained and reconciled against study data. Data queries will be raised for inconsistent, impossible, or missing data. All entries to the study database wi... | [
"Fife and Bluestone 2008",
"Formenti and Demaria 2013",
"Fournel et al 2005",
"Furuse et al 1999",
"Gandara et al 2006",
"Gandhi et al 2018",
"Grimaldi et al 2014",
"Grosso et al 2013",
"Powderly et al 2013",
"Powles et al 2014",
"Qin et al 2016",
"Reck et al 2016",
"Rizvi et al 2015",
"Se... |
NCT03693300 | 11 | SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS |
This study will be conducted in accordance with the protocol and with the following:
- Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and Council for International Organisations of Medical Sciences (CIOMS) International Ethical Guidelines
- Applicable Inter... | [
"Appendix A Regulatory, ethical and study oversight considerations",
"A 1 Regulatory and ethical considerations",
"A 2 Financial disclosure",
"A 3 Informed consent process",
"A 4 Data protection",
"A 5 Committees structure",
"A 6 Dissemination of clinical study data",
"A 7 Data quality assurance",
"... |
NCT03940573 | 1 | Background | [] | |
NCT03940573 | 1.1 | Feasibility Studies | *1.1 Feasibility Studies*
Two feasibility studies were initially conducted to assess the fit and function of the Eclipse System in female subjects. These studies were approved by each site's Institutional Review Board (IRB) as non-significant risk (NSR) device investigations. In total, 86 subjects were fit with the In... | [] |
NCT03940573 | 1.2 | LIFE Pivotal Study | *1.2 LIFE Pivotal Study*
The LIFE Study (Protocol CA003) was a multi-center, prospective, open label clinical trial conducted at 6 centers in the United States. As with the prior studies, all IRBs approved the trial as an NSR investigation. The objective of this pivotal trial was to evaluate the safety and effectivene... | [] |
NCT03940573 | 1.3 | LIBERATE | *1.3 LIBERATE*
The LIBERATE study was a multi-center, prospective, open label clinical trial conducted at 11 centers in the United States. As with the prior studies, all IRBs approved the trial as an NSR investigation. The objective of this study was to evaluate the safety and effectiveness among treatment responders ... | [] |
NCT03940573 | 1.4 | LIBERATE PRO | *1.4 LIBERATE PRO*
The LIBERATE PRO registry study is an on-going, prospective, open label post-market registry to collect patient reported outcomes in subjects using the Eclipse System after completing the LIBERATE study. Patients who completed LIBERATE were offered new Eclipse devices to be used in the subsequent ye... | [] |
NCT03940573 | 1.5 | Description of the Eclipse System | *1.5 Description of the Eclipse System* | [] |
NCT03940573 | 1.5.1 | Overview | The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. Manufactured by Pelvalon (Sunnyvale, CA), it is comprised of a non-surgical device placed in the vagina (referred to as the "Eclipse Insert") and a pressureregulated pump which is used to inf... | [] |
NCT03940573 | 1.5.2 | The Sizing Kit | The Sizing Kit is a set of reusable fitting inserts (Sizers) which consist of the same stainless steel base and medical grade silicone coating as the Eclipse Insert, but without the balloon that is part of the Eclipse system. These reusable Sizers are available in the same base sizes as the Eclipse Insert, and can be r... | [] |
NCT03940573 | 1.5.3 | The Trial Insert | Prior to providing the Eclipse Insert to a subject, the clinician will use the Sizers and the Trial Insert to assess appropriate fit of the Eclipse Insert for each subject. The Trial Insert is composed of a base made of medical grade silicone, polycarbonate, and stainless steel, and a balloon made from medical grade si... | [] |
NCT03940573 | 1.5.4 | The Eclipse Insert | The Eclipse Insert is provided as a non-sterile unit for use by a single patient and is currently available in a range of base sizes with two (2) different balloon sizes. It is composed of a base made of medical grade silicone and stainless steel, and a balloon made of medical grade silicone and polyurethane. The Eclip... | [] |
NCT03940573 | 1.5.5 | The Pump | A pressure-regulated Pump (Figure 2) is provided to inflate and deflate the Insert. The Pump connects to the Insert via the Valve. The Pump has two ports that connect to the Valve: one end for adding air (labeled with a "+") and the other end for removing air (labeled with a "-"). Air is moved through the Pump by squee... | [] |
NCT03940573 | 1.6 | Mechanism of Action of the Eclipse System | *1.6 Mechanism of Action of the Eclipse System*
The Insert is placed in a position similar to other vaginal devices, such as diaphragms, pessaries, and tampons, whose safety profiles are well-established.1,2,3 Insertion and removal, and inflation and deflation of the Insert, are under the control of the subject.
The ... | [] |
NCT03940573 | 1.7 | Regulatory Status of the Eclipse System | *1.7 Regulatory Status of the Eclipse System*
The Eclipse System received marketing clearance from the U.S. Food and Drug Administration (FDA) on November 12, 2015. | [] |
NCT03940573 | 1.8 | Indications for Use | *1.8 Indications for Use*
The Eclipse System is indicated for the treatment of fecal incontinence in adult women. | [] |
NCT03940573 | 2 | Current Study Description | [] | |
NCT03940573 | 2.1 | Study Design | *2.1 Study Design*
PURSUIT is a prospective, open label post-market registry to collect Fitting metrics (e.g. sizes used) and Patient Reported Outcomes in subjects using the Eclipse System in a commercial setting. | [] |
NCT03940573 | 2.2 | Target Population | *2.2 Target Population*
Up to 150 subjects may be enrolled. All women being approached for inclusion into the PURSUIT registry must be adult female patients at participating sites and must have a diagnosis of Fecal Incontinence. She must be a new user of Eclipse or a patient returning to the clinic for her annual f/u ... | [] |
NCT03940573 | 2.3 | Recruitment and Enrollment | *2.3 Recruitment and Enrollment*
All patients who are deemed new suitable clinical candidates for the Eclipse System at a participating site will be invited to participate, as well as patients who are already using Eclipse, and return for an annual renewal visit during the enrollment period.
Potential subjects will b... | [] |
NCT03940573 | 2.4 | Schedule of Events | *2.4 Schedule of Events*
At the Enrollment/Fitting visit, and subsequent in-office visits (as outlined below, in Table 2), patients and clinicians will access online surveys to complete the required data collection (or if necessary, use hard copies). Additionally, subjects will be sent an email with a link to the opti... | [] |
NCT03940573 | 2.5 | Surveys | *2.5 Surveys*
The following questionnaires or surveys will be collected (as outlined in Table 2, above): | [] |
NCT03940573 | 2.5.1 | Bowel Health History | The Bowel Health History survey collects information regarding the patient's history with FI (symptoms and treatments), as well as other bowel health items, such as IBS and Rectal Prolapse. Also included are marketing questions about Eclipse and health insurance. | [] |
NCT03940573 | 2.5.2 | Fitting Metrics | Clinicians will be asked at fitting visits, Eclipse visits, and annual renewals to provide information on the fitting process. For example, how many Inserts were used, and what sizes. | [] |
NCT03940573 | 2.5.3 | Eclipse Experience Assessment | Subjects will be asked, at in-office visits (fitting follow-ups and 12-month visits), to provide feedback on several Eclipse Experience questions related to perceptions of device comfort, satisfaction with usage and features, and impact on daily activities. This assessment includes the Patient Global Impression of Impr... | [] |
NCT03940573 | 2.5.4 | St. Marks (Vaizey) Incontinence Severity Score | The St. Mark's (Vaizey) Incontinence Severity Score is a measure of severity of FI symptoms, which has been shown to correlate with improvement in frequency of FI episodes and subjects' perceptions of relief.4,5,6 This score reflects the severity of FI and ranges from 0 (complete continence) to 24 (complete incontinenc... | [] |
NCT03940573 | 2.5.5 | Optional 3, 6 and 9 Month Surveys | For the completion of online surveys at interim timepoints, a single survey generated using Survey Monkey containing the Eclipse Experience Assessment and the Vaizey score will be sent to subjects via a secure e-mail link or letter for completion approximately every 3 months after registering for the study. The electro... | [] |
NCT03940573 | 3 | Statistics | [] | |
NCT03940573 | 3.1 | Analysis Population | *3.1 Analysis Population*
The Analysis Data Set (ADS) will include all subjects who consent to participate in the PURSUIT registry and have at least an initial fitting, or, in the case of a patient already using Eclipse, be administered an annual renewal Eclipse.
4 Vaizey, CJ, et al Gut 1999;44:77-80 doi:10.1136/gut.... | [] |
NCT03940573 | 3.2 | Outcomes Measurements | *3.2 Outcomes Measurements*
Outcomes Measurements will be assessed at 12 months. Additional assessments may be made for interim (3, 6, 9-month) time points. Where applicable, changes from baseline will be evaluated. Baseline data will be defined as data provided at the initial Fitting Visit. If the patient was previou... | [] |
NCT03940573 | 4 | Other Study Details | [] | |
NCT03940573 | 4.1 | Device Related Injuries and Product Complaints | *4.1 Device Related Injuries and Product Complaints*
All device-related adverse events that result in serious injury will be summarized and tabulated based on the Medical Device Reporting (MDR) database maintained by Pelvalon, as required per 21 CFR 803. Product complaints will be summarized and tabulated based on the... | [] |
NCT03940573 | 4.2 | IRB Approval | *4.2 IRB Approval*
Consistent with 21 CFR 56, and CFR 45 Part 160, and Subparts A and E of Part 164 (the Privacy Rule), this post market clinical study must be approved by an IRB prior to any subjects being enrolled. | [] |
NCT03940573 | 4.3 | Informed Consent | *4.3 Informed Consent*
The Sponsor will use an electronic Informed Consent Form and HIPAA Authorization form which is consistent with regulatory requirements in 21 CFR 50 and 45 CFR 46, and will be approved by the governing IRB prior to use. If sites or patients are unable to unwilling to use the electronic forms, pap... | [] |
NCT03940573 | 4.4 | Monitoring | *4.4 Monitoring*
The study will not be monitored but data will be reviewed on an ongoing basis and sites and/or subjects may be contacted by phone, email, or in writing to provide clarification of discrepant or missing data. | [] |
NCT03940573 | 4.5 | Recordkeeping and Record Retention | *4.5 Recordkeeping and Record Retention*
Pelvalon will maintain evidence via an electronic / digital audit trail that electronic informed consent and HIPAA authorization was obtained prior to PHI being collected.
Pelvalon shall maintain study records for a minimum period of 2 years after the investigation is terminat... | [] |
NCT03940573 | 4.6 | Reports | *4.6 Reports*
The site, with, or without Pelvalon's assistance shall prepare and submit the following complete, accurate, and timely reports:
- Progress reports. Pelvalon shall submit required progress reports to the reviewing IRB, as required by the IRB.
- Final report. Pelvalon shall submit a final report to the re... | [] |
NCT03940573 | 4.7 | Protection of Confidentiality | *4.7 Protection of Confidentiality*
At all times throughout the clinical investigation, confidentiality will be observed by all parties involved. All data will be secured against unauthorized access, by limited access to the survey responses to the clinical research department personnel at Pelvalon. Privacy and confid... | [] |
NCT03940573 | 4.8 | Trial Registration | *4.8 Trial Registration*
This trial will be registered on clinicaltrials.gov website. | [] |
NCT03940573 | 4.9 | Data Collection and Data Management | *4.9 Data Collection and Data Management*
Study data will be collected using surveys that are designed to be completed online. The survey questions will be built using an online survey tool called Survey Monkey. A secure link will be available to the clinician and patients for use during visits, and will be sent to ea... | [] |
NCT03940573 | 4.10 | Compensation to Patients | *4.10 Compensation to Patients*
Patients will be compensated for data collection for any completed online surveys at any of the 3, 6, or 9-month time points. Additionally, patients may be compensated for their in-office visits, including the time it takes for them to complete the surveys in-office. The amounts to be p... | [] |
NCT03940573 | 4.11 | Study Termination | *4.11 Study Termination*
The study may be discontinued at Pelvalon's discretion for the following reasons:
- Occurrence of unexpected adverse events or unanticipated adverse device effects
- New scientific information that shows that the study is no longer valid or necessary
- Insufficient recruitment of subjects
- P... | [] |
NCT03940573 | 4.12 | Final Report | *4.12 Final Report*
A final report will be completed, even if the study is prematurely terminated. The publication of the results will be at Pelvalon's discretion, with the exception of required results posting to clinicaltrials.gov. | [] |
NCT03940573 | 5 | Benefits and Risks | [] |
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