THE ENLIGHTEN STUDY
NCT03261453 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400
Last updated 2024-02-02
Summary
The primary objective of this study is to demonstrate the safety and efficacy of the Elipse Gastric Balloon System for the treatment of obese adults.
Conditions
Interventions
- DEVICE
-
Active Elipse Device
Intervention Device
- DEVICE
-
Elipse Sham Device
Control Device
Sponsors & Collaborators
-
Allurion Technologies
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 22 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-01
- Primary Completion
- 2019-05-01
- Completion
- 2019-05-01
- FDA Device
- Yes
Countries
- United States
Study Locations
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