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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P000008 / PAS002 |
| Date Original Protocol Accepted |
06/05/2001
|
| Date Current Protocol Accepted |
03/28/2016
|
| Study Name |
HERO-002
|
| Device Name |
LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
|
| 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 Objectives |
This is a prospective, multi-center study designed to evaluate the 5-year explant rate.
|
| Study Population |
Subjects must be at least 18 years old and meet one of the following obesity criteria: (a) BMI greater than or equal to 40 kg/m2; (b) BMI greater than or equal to 35 kg/m2 with at least one severe comorbid condition; or (c) 45.5 Kg/100 lbs above ideal body weight.
|
| Sample Size |
The primary analysis of the HERO-002 protocol involves 655 subjects enrolled across up to 17 US and 1 Canadian clinical sites. A sample of 426 subjects will provide 89% power to find a point estimate of 32.5% as statistically superior to the null hypothesis of 39.4%.
|
| Key Study Endpoints |
The primary endpoint is the explant rate over 5 years of follow-up.
The secondary endpoint is the rate of device-related reoperations over 5 years.
|
| Follow-up Visits and Length of Follow-up |
5-years post-implant.
Patients were followed for 5 years post LAP-BAND placement, with assessments occurring at baseline, 3 months, 6 months, and annually thereafter for 5 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
671 subjects
|
| Actual Number of Sites Enrolled |
17 sites
|
| Patient Follow-up Rate |
73.1% at 5 years
|
| Final Safety Findings |
The primary endpoint of the study was met, with a 5-year explant rate of 8.74% (95% CI 6.60%, 10.90%) in the Safety Population being significantly lower than a success criterion of 39.4%.
The 5-year reoperation rate was 7.7%.
|
| Final Effect Findings |
The average %TBWL was -17% through the first year of follow-up and plateaued thereafter until the 5-year visit. Similarly, other anthropometric measures (weight, waist circumference, hip circumference, and BMI) demonstrated decreases during the first year and relatively little change thereafter.
|
| 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 safety and effectiveness endpoints. The main limitation is the limited generalizability of study results. Given the high attrition rate of 26.9% at 5 years, the main study findings may be an over-estimate of the true device performance. PAS data indicate that subjects who did not complete 5 years of follow-up were less successful, in terms of weight loss, compared to those who completed the 5-year study.
|
| Recommendations for Labeling Changes |
Labeling changes are recommended based on the long-term safety and effectiveness results of the PAS and inclusion of real world evidence (including literature and possibly other data sources)
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