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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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New Enrollment Study


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General
Study Status Progress Adequate
Application Number P130019 / PAS002
Date Current Protocol Accepted 01/24/2018
Study Name 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 The objective of this PAS is to evaluate the long-term safety and effectiveness of Maestro.
This is a prospective, multi-center, new enrollment study. The study will include an observational arm and a randomized sub-study. Subjects in the observational arm will receive the device implant and use the vBloc Achieve weight management program.
The randomized sub-study will randomly assign subjects (1:1) to either treatment or control. Subjects assigned to the treatment arm of the randomized sub-study will receive
the device implant and use the vBloc Achieve weight management program. Subjects who are randomized to the control arm of the randomized sub-study will participate in a Control Weight Management (CWM) program during a 6-month control period prior to receiving the device implant and using the vBloc Achieve program. The vBloc Achieve weight management program consists of recommendations regarding
diet, exercise, and behavior modification, and will be utilized be all subjects following their device implantation.
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 200 total subjects with obesity will be implanted with the Maestro Rechargeable System at a minimum of 10 and a maximum of 15 sites.

100 of the subjects will be implanted in an observational portion of the study. 100 subjects will be implanted in a randomized sub-study. Subjects enrolled in the randomized substudy will be randomized 1:1 to either treatment or control arms as described in this protocol.

It is anticipated that approximately 120 subjects will have complete follow-up data at the 5-year visit. 200 subjects with an approximate 8% of attrition per year will provide at least 90% statistical power for the powered 5-year safety objective.
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 a minimum of 10 and a maximum of 15 sites

5 years


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 01/16/2018 Overdue/Received
42 month report 07/13/2018 07/16/2018 Overdue/Received
four year report 01/13/2019    
five year report 01/13/2020    
six year report 01/13/2021    
seven year report 01/13/2022    
eight year report 01/13/2023    
nine year report 01/13/2024    
ten year report 01/13/2025    
final report 03/13/2026    


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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