A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 325
- 试验地点
- 11
- 主要终点
- Percentage of Explants
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Percentage of Explants
时间窗: 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.
次要结局
- Diabetes(5 Year)
- Response to the LAP-BAND(5 Years)
- Obesity related Comorbidity(5 Year)