Obesity (BMI>30), Obesity & Overweight
Conditions
Brief summary
The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).
Detailed description
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: 1. the percentage of patients with at least 5% Total Body Weight Loss (%TBWL) (responder rate) and 2. the mean %TBWL at 48 weeks.
Interventions
DEVICEActive Elipse Device
Intervention Device
Sponsors
Allurion Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Procedure- or Device-Related Serious Adverse Events (SAEs) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate: Percentage of Patients With ≥5% Total Body Weight Loss (%TBWL) | 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. |
| Mean Percent Total Body Weight Loss (%TBWL) | 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. |
Outcome results
None listed