Allurion Gastric Balloon PAS
2026年6月29日 更新者：Allurion Technologies
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
The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
250
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Treatment Arm
All patients eligible to participate will receive the Elipse study device
|
介入装置
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Procedure- or Device-Related Serious Adverse Events (SAEs)
大体时间：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).
|
Through 48 weeks (from first balloon placement on Day 0 through end of second balloon therapy period)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Responder Rate: Percentage of Patients With ≥5% Total Body Weight Loss (%TBWL)
大体时间：Week 48
|
Percentage of patients achieving at least 5% Total Body Weight Loss (%TBWL) at Week 48 (responder rate).
%TBWL is calculated as 100 × (Weight on Day 0 - Weight at visit) / Weight on Day 0. This endpoint evaluates device effectiveness following sequential balloon therapy (up to two balloons).
Analysis is performed on the modified Intent-to-Treat (mITT) population, defined as all patients who successfully received the Allurion Balloon and for whom the balloon was not known to be removed or exited the body within the first 12 weeks after placement.
Responder rate is summarized as a proportion with a 95% two-sided exact confidence interval.
|
Week 48
|
|
Mean Percent Total Body Weight Loss (%TBWL)
大体时间：Week 48
|
Mean Percent Total Body Weight Loss (%TBWL) at Week 48 following sequential balloon therapy (up to two Allurion Balloons placed over the study period).
%TBWL is calculated as 100 × (Weight on Day 0 - Weight at visit) / Weight on Day 0. This endpoint evaluates device effectiveness.
Analysis is performed on the modified Intent-to-Treat (mITT) population and assessed with a 95% two-sided confidence interval using a mixed model of repeated measures (MMRM) approach.
|
Week 48
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月15日
初级完成 (估计的)
2029年2月19日
研究完成 (估计的)
2029年4月20日
研究注册日期
首次提交
2026年6月29日
首先提交符合 QC 标准的
2026年6月29日
首次发布 (实际的)
2026年7月6日
研究记录更新
最后更新发布 (实际的)
2026年7月6日
上次提交的符合 QC 标准的更新
2026年6月29日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.