The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)
Public ClinicalTrials.gov record NCT05368259. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05368259
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,000 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 22 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 12, 2022 (Actual)
- Primary completion
- Nov 1, 2024 (Estimated)
- Completion
- Mar 1, 2025 (Estimated)
- Last update posted
- Oct 26, 2024
2022 – 2025
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| Cedars-Sinai | Los Angeles | California | 90048 | — |
| University of Colorado, Anschutz Health and Wellness Center | Aurora | Colorado | 80045 | — |
| University of Miami, Miller School of Medicine | Doral | Florida | 33166 | — |
| Chicago Institue of Advanced Surgery | Chicago | Illinois | 60657 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | — |
| Saint Luke's Hospital Kansas City | Kansas City | Missouri | 64111 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68106 | — |
| Northwell Health | New Hyde Park | New York | 11004 | — |
| Atrium Health Care | Charlotte | North Carolina | 28204 | — |
| University of Pittsburg Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Vanderbilt Center for Surgical Weight Loss | Nashville | Tennessee | 37204 | — |
| UT Health Science Center at Houston | Bellaire | Texas | 77401 | — |
| Segar MD | San Antonio | Texas | 78258 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05368259, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2024 · Synced Oct 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05368259 live on ClinicalTrials.gov.