Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-26 @ 6:04 PM
Study NCT ID:
NCT05368259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-26
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The AUDACITY Study (AllUrion Device in Adults With Clinical ObesITY)
Sponsor:
Allurion Technologies
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUDACITY
Brief 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.
Detailed Description:
Prospective, open-label, multi-center, randomized study comparing the AGBS + moderate intensity lifestyle modification therapy program vs. moderate intensity lifestyle modification therapy program for the treatment of adults with obesity.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: