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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-ORBERA PAS (OPAS-001)


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General
Study Status Progress Adequate
Application Number P140008 / PAS001
Date Current Protocol Accepted 08/21/2017
Study Name OSB Lead-ORBERA PAS (OPAS-001)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multicenter, open-label new enrollment post-approval study of the safety and effectiveness of ORBERA as an adjunct to weight reduction for obese adults (22 years of age and older) with a Body Mass Index (BMI) of greater than or equal to 30 kg/m2 and BMI of less than or equal to 40 kg/m2. Treatment includes behavioral modification program in conjunction with endoscopic placement of a single ORBERA Intragastric Balloon, filled with saline to an inflation volume between 400cc and 700cc, for 26 weeks followed by endoscopic ORBERA removal. The primary study objective is to demonstrate that the incidence of device and procedure- related Serious Adverse Events (SAEs) after 26 weeks of ORBERA treatment will be no greater than 15%.
The key secondary study objective is to demonstrate that the mean percent Total Body Weight Loss (%TBWL) will be greater than 7.5% at ORBERA treatment conclusion (study week 26).
Study Population Description Male and female subjects, 22 years of age and older, with a BMI of greater than or equal to 30 kg/m2 and less than or equal to 40 kg/m2 who have failed more conservative weight- reduction alternatives, such as supervised diet, exercise, and behavioral modification programs will be enrolled into this study.
Sample Size Up to 284 subjects will be enrolled to yield approximately 255 subjects treated with the ORBERA. Sample size calculations were performed for the primary objective and the key secondary effectiveness objective, with the sample size being driven by the primary objective. Approximately 255 subjects will be treated with the device and will provide 80% power to demonstrate that the device and procedure-related serious adverse event rate is <15%, assuming the rate is no more than 5% than what was observed in the pivotal study. Assuming 255 subjects are treated with ORBERA with an attrition rate of 10% during treatment, there will be approximately 230 subjects completing 26 weeks of treatment. This will provide greater than 99% power to demonstrate that the observed mean %TBWL is more than 7.5% after 26 weeks of ORBERA treatment.

Data Collection The primary endpoint is the incidence of device and procedure-related SAEs after 26 weeks of ORBERA treatment. The key secondary effectiveness endpoint is the %TBWL at week 26.

Other safety endpoints are adverse events including device- and procedure-related AEs and unanticipated Serious Adverse Device Effects (USADEs).

The effectiveness endpoints are %Excess Weight Loss assuming an ideal weight of BMI=25, changes in BMI from baseline, Simplified Nutritional Appetite Questionnaire (SNAQ), and a Subject Satisfaction Survey.

Follow-up Visits and Length of Follow-up Length of follow-up includes 26 weeks of treatment, and 26 weeks of follow-up.


OSB Lead-ORBERA PAS (OPAS-001) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/03/2016 05/20/2016 Overdue/Received
one year report 08/04/2016 08/03/2016 On Time
18 month report 02/02/2017 01/26/2017 On Time
two year report 08/04/2017 08/07/2017 Overdue/Received
30 month report 02/16/2018 02/20/2018 Overdue/Received
three year report 09/03/2018    
four year report 08/04/2019    
final report 12/30/2019    


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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