Allurion Gastric Balloon PAS

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

The primary purpose of this study is to confirm the safety profile results for the Allurion Gastric Balloon System (AGBS).

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.

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.