Not Yet RecruitingNot Applicable

Allurion Gastric Balloon PAS

250 participantsStarted 2026-07-15

Plain-language summary

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

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Procedure- or Device-Related Serious Adverse Events (SAEs)

Timeframe: Through 48 weeks (from first balloon placement on Day 0 through end of second balloon therapy period)

Trial details

NCT IDNCT07684664

SponsorAllurion Technologies

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-02-19

View on ClinicalTrials.gov More Obesity (BMI>30) trials

Who can participate

Age range

22 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.