Endosleeve in Adolescents

Obesity, Childhood Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03778697
• Other study ID #: KingSaudU2018
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 1, 2017
• Est. completion date: May 4, 2019

Study information

• Verified date: May 2019
• Source: King Saud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 4, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Procedure:
• Endoscopic Sleeve Gastroplasty
Endoscopic full-thickness suture system to plicate the greater curvature of the stomach

Locations

Country	Name	City	State
Saudi Arabia	New You Medical Center	Riyadh	Central Region

Sponsors (2)

Lead Sponsor	Collaborator
King Saud University	New You Medical Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss	% total weight loss	One year
Primary	Adverse events	Adverse events, including hospitalization, or unplanned intervention	One year