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Endosleeve in Adolescents

K

King Saud University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Obesity, Childhood

Treatments

Procedure: Endoscopic Sleeve Gastroplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT03778697
KingSaudU2018

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

10 to 21 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Adolescent Endosleeve
Experimental group
Description:
Patients who will undergo endoscopic sleeve gastroplasty
Treatment:
Procedure: Endoscopic Sleeve Gastroplasty

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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