Allurion Gastric Balloon PAS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Elipse Device.
- Who it may be relevant to
- Registry conditions: Obesity (BMI>30), Obesity & Overweight. Basic parameters: 22 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm, Multi-Center, US-based Study to Obtain Data Regarding the Safety and Effectiveness of the Allurion Gastric Balloon System in the Post-Market Setting
Overview
The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).
Detailed description
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 safety endpoint is the percentage of patients who experience a Serious Adverse Event (SAE) that is device or procedure related.
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.
Interventions
- Device Active Elipse Device
Intervention Device
Primary outcome measures
- Incidence of Procedure- or Device-Related Serious Adverse Events (SAEs) [Time frame: Through 48 weeks (from first balloon placement on Day 0 through end of second balloon therapy period)]
Secondary outcome measures (2)
- Responder Rate: Percentage of Patients With ≥5% Total Body Weight Loss (%TBWL) [Time frame: Week 48]
- Mean Percent Total Body Weight Loss (%TBWL) [Time frame: Week 48]
Eligibility criteria
Inclusion criteria
- Age ≥22 years and ≤ 65 years of age
- BMI ≥30 kg/m2 and ≤ 40 kg/m2
- Have signed study specific Informed Consent Form
- Willing to comply with study requirements, including follow-up visits
- Documented negative pregnancy test in women of childbearing potential
- Women of childbearing potential not intending to become pregnant for the duration of study participation. (Note: Women of childbearing potential must not be nursing at the time of treatment).
- Fully ambulatory without any severe chronic orthopedic disease that requires reliance on crutches, walkers or a wheelchair that could preclude exercise during the study
- At least one unsuccessful attempt at weight loss, such as self-administered, commercial, or medically supervised weight loss program attempted within the 24 months preceding enrollment
Exclusion criteria
- Contra-indications to intragastric balloon placement as outlined in Instructions for Use
- Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study, or lead to compliance with study requirements, or that might confound study data.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07684664 · TRL-1000-008 · PAS001 · P250023