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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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ODE Lead-Extended F/u of Premarket Cohort


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General
Study Status Progress Adequate
Application Number P130019 / PAS001
Date Current Protocol Accepted 06/27/2016
Study Name ODE Lead-Extended F/u of Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Open label crossover study from premarket cohort for VBLOC therapy. All remaining subjects either received an implanted device at randomization, have crossed over from to active device after the 12 month visit, or will crossover to the active device.
Study Population Description Transitional. Adolescent B (as adults) : 18-21 years, Adult: >21
Sample Size 203 patients will receive VBLOC therapy. The sponsor anticipates approximately 100 subjects will have complete follow-up data at the 5-year visit.
Data Collection The primary safety objective is to show that the rate of serious adverse events (SAEs) related to the device, implant/revision procedure (including the explant procedure), general surgical procedure, or therapy algorithm is statistically lower than 25% at 5 years.

Other Safety Objectives

To evaluate the long-term (5-year) rate of therapy-related adverse events.

To evaluate the long-term (5-year) rate of device (neuroregulator or lead) malfunction requiring a revision procedure.

To specifically report events involving the lead over 5 years such as lead breakage/fracture, twisting/entanglement, replacement, lead erosion, and bowel/tissue obstruction.

Efficacy Objectives

To evaluate the mean percentage excess weight loss (%EWL) through 5 years

To evaluate the percentage of subjects achieving at least 20% EWL and 25% EWL through 5 years

To evaluate the mean percentage total body weight loss (%TBL) through 5 years

To evaluate the percentage of subjects achieving at least 5% TBL and 10% TBL through 5 years

Other Objectives

To evaluate the long-term (5-year) rate of surgical revision

To evaluate the long-term (5-year) rate of surgical removal of the device

To evaluate the long-term (5-year) rate of surgical removal of the device to undergo magnetic resonance imaging (MRI)

To evaluate change in cardiovascular and metabolic risk factors (blood pressure, lipid levels, triglycerides, blood glucose, HbA1c and waist circumference)

To evaluate change in weight related quality of life (Impact of Weight on Quality of Life Questionnaire-Lite [IWQOL-Lite]) and eating behaviors (Three Factor Eating Questionnaire [TFEQ])
Follow-up Visits and Length of Follow-up 5 years after receiving the active device.

Weekly visits for the first month, every 2 weeks from 4-12 weeks, monthly visits from 3-24 months, and then every 2 months until 5 years.


ODE Lead-Extended F/u of Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 07/15/2015 07/14/2015 On Time
one year report 01/14/2016 01/13/2016 On Time
18 month report 07/14/2016 07/21/2016 Overdue/Received
two year report 01/13/2017 01/12/2017 On Time
three year report 01/13/2018    
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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