Endosleeve in Adolescents

May 4, 2019 updated by: Aayed Alqahtani, King Saud University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Central Region
      • Riyadh, Central Region, Saudi Arabia, 11671
        • New You Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adolescent Endosleeve
Patients who will undergo endoscopic sleeve gastroplasty
Procedure: Endoscopic Sleeve Gastroplasty
Endoscopic full-thickness suture system to plicate the greater curvature of the stomach
Other Names:
  • Endosleeve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Loss
Time Frame: One year
% total weight loss
One year
Adverse events
Time Frame: One year
Adverse events, including hospitalization, or unplanned intervention
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Collaborators

New You Medical Center

Investigators

  • Principal Investigator: Aayed R Alqahtani, MD FRCSC FACS, King Saud University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

May 4, 2019

Study Registration Dates

First Submitted

December 16, 2018

First Submitted That Met QC Criteria

December 16, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 4, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KingSaudU2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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