The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY) (NCT05368259)
A Prospective, Open-Label, Multi-Center, Randomized, Pivotal Safety and Efficacy Study of the Allurion Gastric Balloon System + Moderate Intensity Lifestyle Modification Therapy Program vs. Moderate Intensity Lifestyle Modification Therapy Program for the Treatment of Adults With Obesity
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: HonorHealth Research Institute — Scottsdale, Arizona
Age range: 22 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- HonorHealth Research Institute — Scottsdale, Arizona
- Cedars-Sinai — Los Angeles, California
- University of Colorado, Anschutz Health and Wellness Center — Aurora, Colorado
- University of Miami, Miller School of Medicine — Doral, Florida
- Chicago Institue of Advanced Surgery — Chicago, Illinois
- Indiana University — Indianapolis, Indiana
- Tufts Medical Center — Boston, Massachusetts
- Lahey Hospital and Medical Center — Burlington, Massachusetts
- Saint Luke's Hospital Kansas City — Kansas City, Missouri
- Washington University — St Louis, Missouri
- University of Nebraska Medical Center — Omaha, Nebraska
- Northwell Health — New Hyde Park, New York
- Atrium Health Care — Charlotte, North Carolina
- University of Pittsburg Medical Center — Pittsburgh, Pennsylvania
- Vanderbilt Center for Surgical Weight Loss — Nashville, Tennessee
- UT Health Science Center at Houston — Bellaire, Texas
- Segar MD — San Antonio, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Obesity clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.