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522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

POP AE and Effectiveness rates, registry


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General
522 Number / Requirement Number PS120006 / PSS001
Current Plan Approved 12/15/2015
Study Name POP AE and Effectiveness rates, registry
Root Document Number K082730  K121612 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Elevate Apical/Posterior Study is a prospective, multi-center, post-market cohort study designed to evaluate the long-term efficacy and safety of the Elevate Apical/Posterior Prolapse Repair System compared to Native Tissue Repair in the treatment of posterior or posterior/apical vaginal prolapse in females at least 18 years of age. The study will enroll an equal number of subjects into the Elevate and native tissue repair groups. The treating surgeon together with the subject will decide which treatment the subject will receive.

There are two primary (non-inferiority efficacy and non-inferiority safety) objectives in this study. Both primary objectives need to be met for this study to be considered successful. The primary superiority efficacy objective will be evaluated only if the primary non-inferiority efficacy objective is met. The secondary efficacy objective will be evaluated for non-inferiority and superiority following the same analysis methods as for the primary efficacy objective and it will only be evaluated after the primary non-inferiority efficacy objective is met.



Primary Objective

1. To compare treatment success rate (leading edge of prolapse is at or above the hymen, no feeling of bulge and no retreatment for POP in the target compartment) for the Elevate Apical and Posterior Prolapse Repair System to native tissue repair.

2. To compare the rate of device or procedure related serious adverse events in subjects receiving Elevate Anterior and Apical Prolapse Repair System to native tissue repair.



Secondary Objective

1. To compare treatment success rate (leading edge of prolapse is above the hymen, no feeling of bulge and no retreatment for POP in the target compartment) for the Elevate Apical and Posterior Prolapse Repair System to native tissue repair.

2. To compare the rate of repeat/revision surgery for prolapse arising from the same site/target compartment in subjects receiving Elevate to those with native tissue repair.

3. To compare changes in Quality of Life (QoL) in subjects receiving Elevate to those with native tissue repair.

Study Population Description Device Group: Women implanted with Elevate Apical/Posterior Prolapse Repair Systems.

Comparison Group: Women who underwent traditional native tissue repair (NTR).

Sample Size A total of 494 subjects (247 per study arm) will be enrolled at up to 40 study centers to achieve the primary endpoint of success at 36 months.



Effectiveness: Under the alternative hypothesis: PEAA = 82%, PNTR =80%, a sample size of 135 per group is required at 80% power level with a one-side alpha of 0.05 and a non-inferiority margin of -10%. Assuming 20% attrition rate at 3

years, a minimum of 338 subjects (i.e. 169 per group) are required at the time of enrollment.

Safety: Under the alternative hypothesis: PEAA = 10%, PNTR = 5%, a sample size of 197 per group is required at 80% power level with a one-side alpha of 0.05 and a non-inferiority margin of 12%. Assuming 20% attrition rate at 3 years, a minimum of 494 subjects (i.e. 247 per group) are required at the time of enrollment. Since a minimum sample size of 135 per group at 3 years is required for the primary efficacy objective and it is less than the minimum safety sample size, the sample size required for this study will be 494 assuming a 20% attrition rate.

Data Collection Primary Endpoints

1. The primary efficacy endpoint for subjects undergoing surgical treatment for POP is a dichotomous outcome: surgical treatment "success" or ¿failure." Subjects will be considered a surgical success for this composite outcome if each of the following 3 criteria are met:

¿ Anatomic success (in the targeted compartment)

¿ Posterior Segment: Leading edge anterior prolapse is at or above the hymen (POP-Q point Bp < 0)

¿ Posterior and Apical Segments: Leading edge of the posterior and cervix/vaginal apex prolapse is at or above the hymen (POP-Q point Bp < 0 and C < -(1 /2 TVL))

¿ Subjective success

¿ Subject denies symptoms of vaginal bulging per PFD I-20 question 3, answering ¿No¿ or ¿Yes" but ¿Not at All¿ bothersome (< 2)

¿ No retreatment for POP

¿ No retreatment (target segment): No additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery.



2. Rate of device or procedural related serious adverse events through 36 months post primary prolapse repair.



Secondary Endpoints

1. The secondary efficacy endpoint for subjects undergoing surgical treatment for POP is a dichotomous outcome: surgical treatment ¿success¿ or ¿failure.'' Subjects will be considered a surgical success for this composite outcome if each of the following 3 criteria are met:

¿ Anatomic success (in the targeted compartment)

¿ Posterior Segment : Leading edge of posterior prolapse is above the hymen or POP-Q point Bp < 0

¿ Posterior and Apical Segment: Leading edge of the posterior and cervix/ vaginal apex prolapse is above the hymen (POP-Q point Bp
¿ Subjective success

¿ Subject denies symptoms of vaginal bulging per PFDI-20 question 3, answering "No" or ¿Yes" but ¿Not at All¿ bothersome (< 2)

¿ No retreatment for POP

¿ No retreatment (target segment): No additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery.



2. Rate of repeat/revision surgery for prolapse arising from the same site/target compartment through 36 months post primary prolapse repair

3. Changes in QoL captured at baseline through 36 months utilizing the following validated instruments:

o PFDI 20-Pelvic Floor Distress Inventory

o PFIQ-7-Pelvic Floor Impact Questionnaire

o PISQ-12-Pelvic Organ Prolapse/Urinary Continence Sexual Questionnaire

Follow-up Visits and Length of Follow-up The length of study follow-up is 3 years. Follow-up will be conducted at 2 months, 6 months, 12 months, 18 months, 24 months and 36 months.


POP AE and Effectiveness rates, registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/15/2013 11/15/2013 On Time
1 yr report 05/17/2014 04/28/2014 On Time
18 month report 11/15/2014 10/27/2014 On Time
2 yr report 05/17/2015 04/24/2015 On Time
30 month report 11/16/2015 11/18/2015 Overdue/Received
3 yr report 05/16/2016 04/20/2016 On Time


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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