Clinical trial

Allurion Gastric Balloon PAS

Opening soon · Not applicable · 0 countries · Registry ID NCT07684664

Opening soonNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age22 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity (BMI>30), Obesity & Overweight

Full registry criteria

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.

Treatments and study arms

Active Elipse Device

Device

Intervention Device

Primary outcomes

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).

Study locations

0 locations were listed when this page was built. The first 40 are shown.

No public site location was included in this record. Check the original registry for updates.