A Single-Arm, Multi-Center, US-based Study to Obtain Data Regarding the Safety and Effectiveness of the Allurion Gastric Balloon System in the Post-Market Setting
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Incidence of Procedure- or Device-Related Serious Adverse Events (SAEs)
研究概览
简要总结
The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).
详细描述
The primary endpoint of the study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS) as obtained in the US pivotal clinical study, TRL-1000-0007. The safety endpoint is the percentage of patients who experience a Serious Adverse Event (SAE) that is device or procedure related.
The secondary endpoint is to evaluate device effectiveness after the sequential balloon therapy.
The effectiveness endpoints are evaluated as:
- the percentage of patients with at least 5% Total Body Weight Loss (%TBWL) (responder rate) and
- the mean %TBWL at 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥22 years and ≤ 65 years of age
- •BMI ≥30 kg/m2 and ≤ 40 kg/m2
- •Have signed study specific Informed Consent Form
- •Willing to comply with study requirements, including follow-up visits
- •Documented negative pregnancy test in women of childbearing potential
- •Women of childbearing potential not intending to become pregnant for the duration of study participation. (Note: Women of childbearing potential must not be nursing at the time of treatment).
- •Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study
- •At least one unsuccessful attempt at weight loss, such as self-administered, commercial, or medically supervised weight loss program attempted within the 24 months preceding enrollment
排除标准
- •Contra-indications to intragastric balloon placement as outlined in Instructions for Use
- •Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study, or lead to compliance with study requirements, or that might confound study data.
结局指标
主要结局
Incidence of Procedure- or Device-Related Serious Adverse Events (SAEs)
时间窗: Through 48 weeks (from first balloon placement on Day 0 through end of second balloon therapy period)
Percentage of patients experiencing a procedure- or device-related Serious Adverse Event (Clavien-Dindo Class III or greater) through 48 weeks. The primary objective is to confirm the safety profile of the Allurion Gastric Balloon System (AGBS) in the commercial/post-market setting, consistent with results from the US pivotal study (AUDACITY). All adverse events are coded using MedDRA and classified using the Clavien-Dindo classification system. The endpoint is met if the upper bound of the exact two-sided 95% confidence interval falls below 10%. Analysis is performed on the ITT population (all patients for whom the deployment procedure is attempted).
次要结局
- Responder Rate: Percentage of Patients With ≥5% Total Body Weight Loss (%TBWL)(Week 48)
- Mean Percent Total Body Weight Loss (%TBWL)(Week 48)