Allurion Gastric Balloon PAS

NCT07684664 | Not Yet Recruiting DMC FDA Device

• 3 other identifiers: TRL-1000-008PAS001P250023
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).

Conditions

Obesity (BMI>30); Obesity & Overweight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Responder Rate: Percentage of Patients With ≥5% Total Body Weight Loss (%TBWL)

  Week 48

• Mean Percent Total Body Weight Loss (%TBWL)

  Week 48

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All patients eligible to participate will receive the Elipse study device

Device: Active Elipse Device

Interventions

Active Elipse Device DEVICE

Intervention Device

Treatment Arm

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allurion Technologies: lead

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): February 19, 2029
• Study Completion (Estimated): April 20, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-06