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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enrollment Study


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General
Study Status Progress Inadequate
Application Number P130019 / PAS002
Date Current Protocol Accepted  
Study Name OSB Lead-New Enrollment 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 A prospective, single-arm, multi-center, new enrollment study designed to evaluate the long-term safety and effectiveness of Maestro.
Study Population Description Patients at least 18 years old who have a BMI of 40-45 kg/m2, or a BMI of 35-39.9 kg/m2 with 1 or more obesity related comorbidities and have failed at least 1 supervised weight management program in the past 5 years. There is no control group in this study.
Sample Size A total of 200 subjects will be enrolled at 15 centers (minimum of 10 centers) in the US. At 5 years, a minimum of 120 patients are expected to still be implanted with the device and attend the 5-year clinic visit. It is estimated that the remaining 80 patients will have been explanted prior to the 5-year visit and approximately 50% of the explanted patients will agree to provide additional follow-up data after explant.

Assuming a 25% performance goal, one-sided 0.025 type-I error rate, expected 5-year related SAE rate of 15%, and an 8% rate of explant/dropout per year, it was estimated that the primary safety objective would have at least 90% power with 200 enrolled subjects.

Data Collection The main study endpoint is the 5-year rate of SAEs related

to the device, implant/revision procedure (including explant procedure), general surgical procedure, or therapy. Other study endpoints include: weight loss measured by %TBL

and %EWL; change in obesity-related comorbidities (blood pressure, waist circumference and the number, type and dose of medications for treatment of diabetes, hypertension and dyslipidemia); surgical revision, surgical explant, device explants specifically to undergo MRI, therapy-related AEs, and device (neuroregulator or lead) malfunction requiring a revision procedure; and AEs involving lead breakage/fracture, twisting/entanglement, replacement, lead erosion, and bowel/tissue obstruction.

Follow-up Visits and Length of Follow-up 200 subjects enrolled at 15 centers (minimum of 10 centers) in the US over 28 months.

5 years.


OSB Lead-New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/15/2015 07/24/2015 Overdue/Received
one year report 01/14/2016 01/12/2016 On Time
18 month report 07/14/2016 07/13/2016 On Time
two year report 01/13/2017 01/10/2017 On Time
30 month report 07/13/2017 07/14/2017 Overdue/Received
three year report 01/13/2018    
42 month report 07/13/2018    
four year report 01/13/2019    
five year report 01/13/2020    


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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