Obesity Clinical Trial
Official title:
A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
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.
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.
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