NCT07684664Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 29 Jun 2026
- Start date
- 15 Jul 2026
- Primary completion date
- 19 Feb 2029
- Lead sponsor
- Allurion Technologies
- Diseases
- Obesity
- NCT number
- NCT07684664
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 15 Jul 2026 to the primary completion date, 19 Feb 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Contra-indications to intragastric balloon placement as outlined in Instructions for Use
Who the study is looking for
- 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
Age in the registry: 22 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.