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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a teenager aged 14-19 and clinically very overweight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
change from baseline weight
Trial Design
1Treatment groups
Experimental Treatment
Group I: gastric ballon placementExperimental Treatment1 Intervention
will receive gastric balloon placed via endoscopy
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,408 Previous Clinical Trials
17,343,187 Total Patients Enrolled
70 Trials studying Obesity
270,184 Patients Enrolled for Obesity
Monique T Barakat, MDPrincipal InvestigatorStanford University
Roberto Gugig, MDPrincipal InvestigatorStanford University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend sessions every 2 to 4 weeks and follow lifestyle advice.I have had serious inflammation or ulcers in my digestive system.I have had surgery on my esophagus or stomach, or I have a history of blocked intestines.I am a teenager aged 14-19 and clinically very overweight.I have a large hiatus hernia or a smaller one with severe acid reflux.
Research Study Groups:
This trial has the following groups:- Group 1: gastric ballon placement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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