NCT03778697

Endosleeve in Adolescents

Safety and Efficacy of Endoscopic Sleeve Gastroplasty in Obese Children and Adolescents

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: King Saud University · Academic / Other
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Accepted

Summary

In this study, the investigators assess the safety and efficacy of endoscopic sleeve gastroplasty in adolescents with obesity.

Detailed description

Endoscopic bariatric therapy (EBT) is an emerging, rapidly evolving field that aims to serve as a middle ground between safe, albeit poorly effective medical weight loss strategies and drastic but effective bariatric surgery. Endoscopic sleeve gastroplasty (ESG) is a procedure that restricts the stomach to a sleeve-like configuration by utilizing full-thickness sutures that plicate the greater curvature of the stomach. Emerging data from adult populations shows an acceptable safety, tolerability and efficacy profile. Based on analysis that confirmed the safety and efficacy of ESG in adult patients who undergo the procedure under a standardized protocol and clinical care pathway, the investigators planned to study its effects on adolescents in a specialized center that offers surgical, endoscopic, and medical management of obesity under a standardized protocol and care pathway.

Conditions

• Obesity, Childhood

Interventions

Type	Name	Description
PROCEDURE	Endoscopic Sleeve Gastroplasty	Endoscopic full-thickness suture system to plicate the greater curvature of the stomach

Timeline

• Start date: 2017-12-01
• Primary completion: 2019-04-30
• Completion: 2019-05-04
• First posted: 2018-12-19
• Last updated: 2019-05-07

Locations

1 site across 1 country: Saudi Arabia