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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-LBMI-002


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General
Application Number P000008 S017/ PAS001
Current Plan Approved 08/15/2011
Study Name OSB Lead-LBMI-002
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 A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multiple-center, non-randomized, cohort study
Study Population Description Patients enrolled in the study LBMI-001:

Obesity (BMI ¡Ý 30 kg/m2 and < 35 kg/m2 with or without comorbid conditions and BMI ¡Ý 35 kg/m2 and < 40 kg/m2 without any severe comorbid conditions) at time of LBMI-001 enrollment

Sample Size Up to 149 patients
Data Collection Effectiveness: The percent of subjects treated with the LAP-BAND® who achieve successful weight loss, at 5 years post- implantation, will be statistically non-inferior to 60%, where successful weight loss is defined as at least 30% Excess Weight Loss (EWL).



Safety: The primary measure is the percentage of those subjects who are explanted within 5 years postimplantation. Additionally safety measurements will include the incidence of adverse events, by severity and relation to device, observed over the study assessment period.

Follow-up Visits and Length of Follow-up 5 years post implantation

Final Study Results
Number of Patients 149 subjects
Number of Sites 7 sites
Follow-up Rate 72.5% (108/149)
Safety Findings The 5-year explant rate (including explants with replacement) was 14.8%. Therefore, the primary safety endpoint that the 5-year explant rate is significantly lower than 32.5% has been met.
Effect Findings 76.9% of subjects attained successful weight loss (defined as ¡Ý 30% excess weight loss) at 5 years. Therefore, the main effectiveness endpoint that 5-year successful weight loss will be noted in at least 60% of patients has been met.
Strengths & Weaknesses Strengths of this study include a multi-center, prospective design of adequate sample size for long-term (5-year) evaluation of the primary safety and effectiveness endpoints. The main limitation is the limited generalizability of results, since this post-approval study is an extended follow-up of the premarket cohort. Given that this study is likely comprised of the best responders from the pivotal trial, the main study findings may be an over-estimate of the true device performance in the lower BMI indication.
Label Changes Labeling changes are recommended based on the long-term safety and effectiveness results of the post-approval study.


OSB Lead-LBMI-002 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/17/2011 12/05/2011 Overdue/Received
one year report 02/16/2012 02/15/2012 On Time
18 month report 08/16/2012 08/17/2012 Overdue/Received
two year report 02/15/2013 02/15/2013 On Time
three year report-FINAL 02/15/2014 02/07/2014 On Time


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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