Trial Summary
What is the purpose of this trial?
Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.
Research Team
RG
Roberto Gugig, MD
Principal Investigator
Stanford University
MT
Monique T Barakat, MD
Principal Investigator
Stanford University
Eligibility Criteria
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.Inclusion Criteria
I can attend sessions every 2 to 4 weeks and follow lifestyle advice.
I am a teenager aged 14-19 and clinically very overweight.
Exclusion Criteria
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 have a large hiatus hernia or a smaller one with severe acid reflux.
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Treatment Details
Interventions
- Gastric Balloon (Intra-gastric Device)
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: gastric ballon placementExperimental Treatment1 Intervention
will receive gastric balloon placed via endoscopy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Trials
2,527
Recruited
17,430,000+
Dr. Richard A. Miller
Stanford University
Chief Executive Officer since 2023
Stanford University, MD
Dr. Robert Schott
Stanford University
Chief Medical Officer since 2021
University of Michigan, MD