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Intra-gastric Device

Gastric Balloon for Obesity

N/A
Waitlist Available
Led By Monique T Barakat, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI > 3.5 SD)
Be younger than 65 years old
Must not have
History of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis
Previous esophageal or gastric surgery or history of intestinal obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a balloon placed in the stomach can help obese and morbidly obese adolescents lose weight.

Who is the study for?
This trial is for obese or morbidly obese teens aged 14-19 with a BMI >3.5 SD who can commit to regular support sessions and lifestyle changes. It's not for those with significant psychological disorders, past stomach surgeries, large hiatus hernias, severe reflux symptoms, inflammatory GI diseases, or congenital anomalies.
What is being tested?
The study tests the effectiveness of an endoscopically placed gastric balloon in combination with behavioral support to help overweight adolescents lose weight and improve their health.
What are the potential side effects?
Potential side effects may include discomfort or pain in the abdomen, nausea and vomiting shortly after placement, potential risks of sedation required for the procedure, and rare complications like balloon deflation or gastrointestinal obstruction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a teenager aged 14-19 and clinically very overweight.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had serious inflammation or ulcers in my digestive system.
Select...
I have had surgery on my esophagus or stomach, or I have a history of blocked intestines.
Select...
I have a large hiatus hernia or a smaller one with severe acid reflux.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: gastric ballon placementExperimental Treatment1 Intervention
will receive gastric balloon placed via endoscopy

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,798 Total Patients Enrolled
71 Trials studying Obesity
270,194 Patients Enrolled for Obesity
Monique T Barakat, MDPrincipal InvestigatorStanford University
Roberto Gugig, MDPrincipal InvestigatorStanford University

Media Library

Gastric Balloon (Intra-gastric Device) Clinical Trial Eligibility Overview. Trial Name: NCT04209842 — N/A
Obesity Research Study Groups: gastric ballon placement
Obesity Clinical Trial 2023: Gastric Balloon Highlights & Side Effects. Trial Name: NCT04209842 — N/A
Gastric Balloon (Intra-gastric Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04209842 — N/A
~13 spots leftby Aug 2026
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