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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 below
Select...
I am a teenager aged 14-19 and clinically very overweight.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,396 Previous Clinical Trials
17,341,535 Total Patients Enrolled
70 Trials studying Obesity
270,184 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility criteria to participate in this clinical trial?

"This particular experiment is seeking 20 adolescent participants, aged between 14 and 19 years old, who suffer from obesity or morbidity. It is essential that these patients are able to attend bi-weekly checkups with our support personnel and comply with the recommended lifestyle changes for efficacy in this trial."

Answered by AI

Are there still openings for participants in this investigation?

"According to the clinicaltrials.gov page, recruitment for this medical research has closed as of November 4th 2022. Although no longer open, there are still 95 other studies actively recruiting participants at this time."

Answered by AI

Are adolescents of qualifying age being included in this trial?

"For this particular trial, prospective patients have to be aged between 14 and 19 years old. Additionally, there are 6 studies for participants below 18 years of age as well as 75 trials that cater to individuals above the senior citizen threshold."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Lucille Packard Children's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effectiveness Gastric Balloon in Obese Adolescents
Roberto Gugig 2024. "Effectiveness Gastric Balloon in Obese Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04209842.
All > Morbid Obesity
~13 spots leftby Aug 2026
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