NCT03778697

Endosleeve in Adolescents

Completed Phase 1, PHASE2 Last updated 7 May 2019

What this trial tests

Phase 1, PHASE2 trial testing Endoscopic Sleeve Gastroplasty in Obesity, Childhood in 100 participants. Completed in 4 May 2019.

Timeline

1 December 2017

Primary endpoint
30 April 2019

4 May 2019

Quick facts

Lead sponsor	King Saud University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 December 2017
Primary completion	30 April 2019
Estimated completion	4 May 2019
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Endoscopic Sleeve Gastroplasty

Conditions studied

• Obesity, Childhood — all drugs for Obesity, Childhood →

Sponsor

King Saud University

Who can join

Adults 10 to 21, any sex, with Obesity, Childhood. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Endoscopic Sleeve Gastroplasty in 109 Consecutive Children and Adolescents With Obesity: Two-Year Outcomes of a New Modality.
   Alqahtani A, Elahmedi M, Alqahtani YA, Al-Darwish A. · · 2019 · cited 29× · PMID 31658128 · DOI 10.14309/ajg.0000000000000440