A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study

Conditions
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Obesity, Overweight

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Explants | The primary objective is to assess the percentage of patients who experience an explant of the LAP BAND System within 5 years of implantation. | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to the LAP-BAND | Secondary objectives include assessment of patients who respond to the LAP BAND® System at 5 years, where response is defined as achieving at least 7%Total Body Loss (TBL), assessment of prevalence of diabetes at 5 years, and assessment of changes in obesity-related comorbid conditions at 5 years. | 5 Years | 
| Diabetes | Assessment of prevalence of diabetes at 5 years | 5 Year | 
| Obesity related Comorbidity | Assessment of changes in obesity-related comorbid conditions at Year 5 | 5 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lap Band