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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 Oct 26, 2026, 10:53 PM 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

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

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
Feb 1, 2018 (Actual)
Primary completion
May 1, 2019 (Actual)
Completion
May 1, 2019 (Actual)
Last update posted
Feb 2, 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 2, 2024 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03261453 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →