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Gastric Balloon for Obese Adolescents

This study is looking at how well a gastric balloon works for weight loss in teenagers who are obese or morbidly obese. A gastric balloon is a non-surgical device placed inside the stomach to help you feel full. The study will also include behavioral support to help with lifestyle changes. We want to see how much weight participants lose after 6 months. To join, you must be between 14 and 19 years old, clinically obese or morbidly obese, and able to attend regular support sessions. We are planning to enroll 20 participants, but the current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
What's involved
You would need to attend biweekly to monthly sessions with a support team and follow advised lifestyle changes. The primary measurement for weight change is at 6 months.
Compensation
Not stated in the trial record.
Follow-up
The main measurement for weight loss is taken at 6 months after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04209842

Effectiveness Gastric Balloon in Obese Adolescents

UNKNOWN
NAAges 14–19InterventionalTreatment
Stanford University
~20 participants
Updated 2023-12-21 on ClinicalTrials.gov
What's tested:gastric balloon

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
change from baseline weight
Measured over 6 months

Conditions

Obesity, Morbid

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Roberto Gugig, MD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Monique T Barakat, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI \> 3.5 SD)
Are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised

Exclusion

Previous esophageal or gastric surgery or history of intestinal obstruction;
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
Hiatus hernia \>5 cm or \<5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion);
History of significant psychological disorder (permission sought from lead care giver).

What this trial measures

  • change from baseline weight6 months