CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
ORBERA™ Intragastric Balloondevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03233048
NCT03233048N/ACompleted
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Safety and Efficacy of Endoscopically Placed Intragastric Balloon in Obese Adolescents With Comorbidities - A Pilot Study

Imad Absah·interventional·Posted Jul 28, 2017·Updated May 3, 2022

In Brief

A clinical study evaluating ORBERA™ Intragastric Balloon for Obesity. Completed, enrolled 5 participants across 1 site.

Detailed Summary

The reason we are doing this research is to get information about the ORBERA™ Intragastric Balloon to learn if it is safe and if it works. We want to learn if older teenagers who are overweight will lose weight and if their other medical problems will get better. ORBERA™ is a special balloon approved by the FDA for overweight adults, and we would like to try using it for overweight teenagers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 28, 2017
Enrollment StartOct 26, 2017
Primary CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 8.9 years ago

Interventions

ORBERA™ Intragastric Balloondevice

The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.