|
|
| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P000008 S017/ PAS002 |
| Date Original Protocol Accepted |
02/16/2011
|
| Date Current Protocol Accepted |
03/03/2016
|
| Study Name |
Apollo-001
|
| Device Name |
LAP-BAND
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Device Subjects Serve as Own Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
NOTE: The PAS requirement for the lower BMI patients is being closed prior to its completion because in clinical practice LAP-BAND is not widely used for the lower BMI patients. Continuing enrollment would not have added value. In addition, the label already reflects long-term performance for the higher BMI patients. Therefore, no labeling update is needed at this time.
New enrollment study designed to evaluate the safety and effectiveness of Lap-Band. Prospective single-arm cohort.
|
| Study Population |
Patients with BMI >=30 kg/m2 and <40 kg/m2 and 1 or more obesity-
related comorbidities. There is no control group in this study.
|
| Sample Size |
325 subjects will be enrolled across 20 U.S. sites. Assuming 20% attrition, a sample size of 260 subjects at 5 years provides 84% power to test the hypothesis that the reduction in diabetes prevalence at 5 years will be at least 5%. This will be tested using a 1-sided exact binomial test with a 5% significance level. Up to 65 subjects can be enrolled per site.
|
| Key Study Endpoints |
Primary safety endpoint: 5-year explant rate; Secondary effectiveness
endpoints: 5-year responder rate (where response is defined as achieving >=
7% TBL), diabetes prevalence at 5 years, and change in obesity-related comorbidities at 5 years compared to baseline
|
| Follow-up Visits and Length of Follow-up |
10 Years - In-office visits before and after surgery, at 1, 2, 3, and 6 months, and 1, 3, 5,
7, and 10 years after surgery. Patients will complete a questionnaire at 2, 4,
6, 8, and 9 years after surgery.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
175 patients received device implant, 32 with low BMI of 30.00- 34.99
|
| Actual Number of Sites Enrolled |
13
|
| Patient Follow-up Rate |
92.2% at 1 year (based on the number of subjects (77) eligible for the 1-year visit)
|
| Final Safety Findings |
The 1-year rates for device explant, band slippage, and erosion are same at 3.1% for low BMI patients of 30.00-34.99. The 1-year rate is 0% for device explant, 1.4% for slippage, and 0% for erosion in patient with BMI of 34.00-39.99 The long-term safety information is available from the 5-year HERO-002 study.
|
| Final Effect Findings |
Final effectiveness findings (key endpoints):
The 1-year responder rate is 73.7% for low BMI patients (30.00-34.99), and 86.2% for patients with BMI of 34.00-39.99. The long-term effectiveness information is available from the 5-year the HERO-002 study.
|
| Study Strengths & Weaknesses |
Strength: Long-term data available through 5-years of follow-up from the 5-year the HERO-002 study.
Weaknesses: Slow study enrollment was observed for lower BMI patients, since in clinical practice the device is not widely used for lower BMI patients. Therefore, the study was closed prior to its completion, since enrolling more patients would not have added value.
|
| Recommendations for Labeling Changes |
The label already reflects long-term performance; therefore, no additional labeling update is needed at this time.
|
