A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Apollo Endosurgery, Inc.
- Enrollment
- 325
- Locations
- 11
- Primary Endpoint
- Percentage of Explants
Study Overview
Brief Summary
This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and < 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation.
The reason your study has been terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.
Detailed Description
FDA post-approval study designed to collect prospective data in a real-world setting to evaluate long-term safety and effectiveness of the LAP BAND® System in patients with a BMI of ≥ 30 kg/m2 and < 40 kg/m2 and one or more comorbid conditions. The Apollo-001 Study is a prospective, 10 year, multicenter study of patients who have decide to undergo implantation of the LAP-BAND AP® system. Outcomes include device explants, changes in weight, comorbid condition status, device- and procedure-related AEs, and reoperations.
The LBMI study was part of the condition of approval (CoA) for the Lap-Band device. It was terminated because it was no longer required to fulfill the condition of approval for the device. Apollo was able to fulfill the condition of approval (CoA) for the Lap-Band device by using data from published literature and another recently completed study (OSB Lead-Hero-002 study) which had long-term safety and effectiveness data addressing the conditions of approval.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •LAP-BAND® System placed in a facility in the United States
- •BMI ≥ 30 kg/m2 and < 40 kg/m2 prior to LAP-BAND® placement
- •Presence of 1 or more obesity-related comorbidities prior to LAP-BAND® placement
- •Aged 18 or older
Exclusion Criteria
- •Prior bariatric surgery.
- •Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter patterns of care, use of medications or the outcomes under study.
- •Vulnerable patients or those unable to exercise free informed consent.
- •Inability to complete the questionnaires.
- •Patients who are addicted to alcohol and/or drugs.
Outcomes
Primary Outcomes
Percentage of Explants
Time Frame: 5 Years
The primary objective is to assess the percentage of patients who experience an explant of the LAP BAND System within 5 years of implantation.
Secondary Outcomes
- Diabetes(5 Year)
- Response to the LAP-BAND(5 Years)
- Obesity related Comorbidity(5 Year)