Safety and Efficacy of Endoscopic Sleeve Gastroplasty in Obese Children and Adolescents
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- King Saud University
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Weight Loss
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Adolescent Endosleeve
Patients who will undergo endoscopic sleeve gastroplasty
Intervention: Endoscopic Sleeve Gastroplasty (Procedure)
Outcomes
Primary Outcomes
Weight Loss
Time Frame: One year
% total weight loss
Adverse events
Time Frame: One year
Adverse events, including hospitalization, or unplanned intervention
Secondary Outcomes
No secondary outcomes reported
Investigators
Aayed Alqahtani
Professor of Surgery, Director of Obesity Chair
King Saud University