Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support

Stanford University1 site in 1 country20 target enrollmentSeptember 2024

ConditionsObesity, Morbid

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity, Morbid
Sponsor: Stanford University
Enrollment: 20
Locations: 1
Primary Endpoint: change from baseline weight
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2024

End Date

August 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Roberto Gugig

professor of pediatrics

Stanford University

Eligibility Criteria

Inclusion Criteria

•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 Criteria
•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).