Endosleeve in Adolescents

Phase 1

Completed

• Conditions: Obesity, Childhood
• Interventions: Procedure: Endoscopic Sleeve Gastroplasty

• Registration Number: NCT03778697
• Lead Sponsor: King Saud University

Brief 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.

Study Timeline

• Study Start: 2017-12-01
• Study First Submitted: 2018-12-16
• Study First Submitted QC: 2018-12-16
• Study First Posted: 2018-12-19
• Primary Completion: 2019-04-30
• Status Verified: 2019-05
• Study Completion: 2019-05-04
• Last Update Submitted: 2019-05-04
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• BMI that is >120% of the 95th percentile for age and gender
• Written informed assent/consent, with concomitant parental consent for patients aged ≤17 years

Exclusion Criteria

• Age <10 years
• Age >21 years
• Presence of large hiatal hernia
• Previous gastric surgery
• Cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adolescent Endosleeve	Endoscopic Sleeve Gastroplasty	Patients who will undergo endoscopic sleeve gastroplasty

Primary Outcome Measures

Name	Time	Method
Weight Loss	One year	% total weight loss
Adverse events	One year	Adverse events, including hospitalization, or unplanned intervention

Trial Locations

Locations (1)

New You Medical Center; 🇸🇦 Riyadh, Central Region, Saudi Arabia