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Intragastric Balloon in Obese Adolescents With Comorbidities

NCT03233048 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-05-03

Study results available
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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.

Conditions

Interventions

DEVICE

ORBERA™ Intragastric Balloon

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.

Sponsors & Collaborators

  • Imad Absah

    lead OTHER

Principal Investigators

  • Imad Absah, M.D. · Study Principal Investigator

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-26
Primary Completion
2020-12-01
Completion
2020-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03233048 on ClinicalTrials.gov