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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Solesta - Long Term Study


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General
Application Number P100014 / PAS001
Current Plan Approved 02/26/2014
Study Name OSB Lead-Solesta - Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective, single-arm, multicenter, observational clinical study.
Study Population Description Adults 18-75 years old with FI who have failed conservative therapy.
Sample Size It is anticipated that at least 244 patients and as many as 293 patients may be

enrolled in this Solesta PAS to obtain at least 150 evaluable patients from

approximately 15-20 sites with more sites to be added if necessary to meet

accrual within the 2-3 year target

Data Collection The primary efficacy endpoint of this study is freedom from FI

reintervention.



The primary safety endpoint will be the occurrence of device-related AEs. Secondary Endpoints:

The secondary safety endpoint will be the occurrence of peri-injection device-related infectious AEs.







The secondary performance endpoints will be: 1) the presence or absence of implants (as assessed by the clinician) and 2) determine if any local shift

has occurred at 6 and 36 months after the last Solesta treatment (as assessed

by the clinician).



Secondary Efficacy Endpoints:



¿ Fecal Incontinence Quality of Life will be assessed by the Rockwood instrument, at baseline, 6, 12, and 36 months after last Solesta treatment.

¿ Cleveland Clinic Florida Fecal Incontinence Score will be collected at baseline, 6, 12, and 36 months after last Solesta treatment.

¿ A patient global assessment of improvement (i.e., GPE-Score; 7- Point Scale) will be performed at 6, 12 and 36 months after last

Time to FI reintervention will be measured from the date of last

treatment with Solesta to the date of first FI reintervention.

Follow-up Visits and Length of Follow-up 36 months

3, 6, 12, 24 and 36 months


OSB Lead-Solesta - Long Term Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
case report forms 10/27/2011 10/27/2011 On Time
six month report 11/25/2011 12/16/2011 Overdue/Received
one year report 05/26/2012 06/13/2012 Overdue/Received
18 month report 11/24/2012 01/22/2013 Overdue/Received
two year report 05/26/2013 06/19/2013 Overdue/Received
three year report 07/10/2014 07/10/2014 On Time
four year report 05/26/2015 12/15/2015 Overdue/Received
five year report 07/29/2016 08/01/2016 Overdue/Received
six year report 07/29/2017    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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