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Completed

NCT Number: NCT03778697

Endosleeve in Adolescents

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

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

10 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New You Medical Center

Riyadh, Central Region, 11671, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Sleeve Gastroplasty

Procedure

Endoscopic full-thickness suture system to plicate the greater curvature of the stomach

Other names: Endosleeve

Primary outcomes

  1. Weight Loss

    Time frame: One year

    % total weight loss

  2. Adverse events

    Time frame: One year

    Adverse events, including hospitalization, or unplanned intervention

Sponsors and collaborators

Lead sponsor

King Saud University

Other

Collaborators

  • New You Medical Center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2018
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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