Clinical Trial

The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)

Study acronym: AUDACITY
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated October 26, 2024 (before its estimated November 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
The objective for this clinical study is to provide FDA with clinical evidence regarding the effectiveness and safety of the AGBS + moderate intensity lifestyle modification therapy program, indwell time of the AGBS inside the stomach, and outcomes at 48 weeks.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2022-05-06; most recent amendment 2026-05-10.
Status change: Active, Not Recruiting → Completed 2026-05-10
Status change: Recruiting → Active, Not Recruiting 2023-09-18
Trial Details
NCT Number NCT05368259
Lead Sponsor Allurion Technologies
Conditions Obesity
Enrollment 1,000 participants
Start Date 2022-05-12
Primary Completion 2024-11-01 (estimated)
Study Completion 2025-03-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-26