Allurion Gastric Balloon PAS

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight; Obesity (BMI>30)
• Intervention / Treatment: Device: Active Elipse Device

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; All patients eligible to participate will receive the Elipse study device	Device: Active Elipse Device; Intervention Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Procedure- or Device-Related Serious Adverse Events (SAEs)	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate: Percentage of Patients With ≥5% Total Body Weight Loss (%TBWL)	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)	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

Collaborators and Investigators

• Sponsor: Allurion Technologies

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): February 19, 2029
• Study Completion (Estimated): April 20, 2029

Study Registration Dates

• First Submitted: June 29, 2026
• First Submitted That Met QC Criteria: June 29, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 29, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: TRL-1000-008; PAS001 (Registry Identifier: FDA Post-Approval Studies (PAS) Database); P250023 (Other Identifier: FDA Premarket Approval (PMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No