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NCT04209842 Clinical Trial

Effectiveness Gastric Balloon in Obese Adolescents

Obesity, Morbid Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04209842
Other study ID # 52936
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date August 2026

Study information
Verified date December 2023
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 20
Est. completion date August 2026
Est. primary completion date August 2026
Accepts healthy volunteers No
Gender All
Age group 14 Years to 19 Years
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• gastric balloon
non surgical weight loss via placement of gastric balloon

Locations
Country Name City State
United States Lucille Packard Children's Hospital Palo Alto California

Sponsors (1)
Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary change from baseline weight 6 months
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