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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Allurion Gastric Balloon PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P250023 / PAS001
Date Original Protocol Accepted 02/20/2026
Date Current Protocol Accepted 02/20/2026
Study Name Allurion Gastric Balloon PAS
Device Name Allurion™ Gastric Balloon System
Clinical Trial Number(s) NCT05368259 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives Prospective Cohort Study: The primary objective of this study is to assess the continued safety and performance of
the AGBS in the commercial setting.
Study Population Patients aged 22-65 who have a BMI of greater than or equal to 30 kg/m² and less than or equal to 40 kg/m²; and have failed to lose weight through diet and exercise. Patients willing to commercially purchase the AGBS.
Sample Size 250 patients
Key Study Endpoints The primary endpoint of the study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS) as obtained in the US pivotal clinical study,
TRL-1000-0007. The secondary endpoint is to evaluate device effectiveness after the sequential balloon therapy.
The effectiveness endpoints are evaluated as: 1) the percentage of patients with at least 5% Total Body Weight Loss (%TBWL) (responder rate) and
2) the mean %TBWL at 48 weeks.
The primary safety endpoint is the percentage of patients who experience a Serious Adverse Event (SAE; Clavien-Dindo Class III or greater) that is device-or procedure-related. The secondary safety endpoint is the percentage of patients, frequency, and severity of individual Adverse Events (AEs) that are device- or procedure-related (e.g., abdominal pain, nausea, vomitting, bloating) during the balloon therapy period.
Follow-up Visits and Length of Follow-up 48 weeks


Allurion Gastric Balloon PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 08/21/2026 08/20/2026 On Time
1 year report 02/20/2027    
18 month report 08/21/2027    
2 year report 02/20/2028    
30 month report 08/20/2028    
3 year report 02/19/2029    
42 month report 08/20/2029    
4 year report 02/19/2030    


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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