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Completed Not applicable Interventional

THE ENLIGHTEN STUDY

ClinicalTrials.gov ID: NCT03261453

Public ClinicalTrials.gov record NCT03261453. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 24, 2026, 6:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Multi-Center, Phased, Pivotal Safety and Efficacy Study Comparing the Elipse™ Gastric Balloon System vs. Sham for the Treatment of Obese Adults

Study identification

NCT ID
NCT03261453
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Allurion Technologies
Industry
Enrollment
400 participants

Conditions and interventions

Interventions

  • Active Elipse Device Device
  • Elipse Sham Device Device

Device

Eligibility (public fields only)

Age range
22 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2018
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019
Last update posted
Feb 1, 2024

2018 – 2019

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Honor Health Scottsdale Arizona 85258
University of Colorado, Anschutz Health and Wellness Center Aurora Colorado 80045
Bariatric Institute of Greater Chicago Bolingbrook Illinois 60440
Surgical Specialists of Louisiana Metairie Louisiana 70001
Holyoke Medical Center Holyoke Massachusetts 01002
Weill Cornell Medicine, Division of Endocrinology, Diabetes and Metabolism New York New York 10065
University of Pennsylvania Medical Center (UPMC) Pittsburgh Pennsylvania 15213
CHI Metabolic and Bariatric Care Chattanooga Tennessee 37421
MidSouth Bariatrics Memphis Tennessee 38120
Vanderbilt Center for Surgical Weight Loss Nashville Tennessee 37204
UT Physicians Minimally Invasive Surgeons of Texas (UTMIST) Bellaire Texas 77401
Charlottesville Medical Research Center Charlottesville Virginia 22291

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03261453, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 1, 2024 · Synced Jul 24, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03261453 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →