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NCT03261453 · ClinicalTrials.gov registry record · NA
THE Enlighten Study
A NA study, sponsored by Allurion Technologies.
- Completed
- Registry status
- NA
- Development phase
- 400
- Enrollment target
NCT03261453: Completed NA study, sponsored by Allurion Technologies.
NCT03261453 is a NA study that has completed, run by Allurion Technologies. The registered enrollment target is 400 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03261453, a NA study, has completed, sponsored by Allurion Technologies.
- COMPLETED
- Registry status
- NA
- Development phase
- 400 participants
- Enrollment target
Study 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.
Primary Outcome
An inferential test of whether the Treatment Group Responder Rate (RR) dichotomized at 5% TBWL at 16 weeks is significantly greater than 35%.
Interventions
- DEVICE Active Elipse Device
- DEVICE Elipse Sham Device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2019-05-01 |
| Phase | NA |
What the finished NCT03261453 record still lists
NCT03261453 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Active Elipse Device is the first listed.
NCT03261453 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03261453 about?
NCT03261453 is a clinical study titled "THE Enlighten Study". 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.
What is the current status of trial NCT03261453?
This trial is currently completed. It is a NA study. The enrollment target is 400 participants. The study started on 2018-02-01. Estimated completion is 2019-05-01.
What interventions are being tested in trial NCT03261453?
The interventions under investigation include: Active Elipse Device (DEVICE), Elipse Sham Device (DEVICE).
Who is sponsoring clinical trial NCT03261453?
This trial is sponsored by Allurion Technologies, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03261453's enrollment target sits among peer trials
400 246th of 2000 higher than 1,734 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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