|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P000008 S017/ PAS001 |
| Date Original Protocol Accepted |
02/16/2011
|
| Date Current Protocol Accepted |
08/15/2011
|
| Study Name |
LBMI-002
|
| Device Name |
LAP-BAND
|
| Clinical Trial Number(s) |
NCT00570505
|
| 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 Objectives |
Multiple-center, non-randomized, cohort study
|
| Study Population |
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
|
| Key Study Endpoints |
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
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
149 subjects
|
| Actual Number of Sites Enrolled |
7 sites
|
| Patient Follow-up Rate |
72.5% (108/149)
|
| Final 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.
|
| Final Effect Findings |
76.9% of subjects attained successful weight loss (defined as greater than or equal to 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.
|
| Study 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.
|
| Recommendations for Labeling Changes |
Labeling changes are recommended based on the long-term safety and effectiveness results of the post-approval study.
|
