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Endosleeve in Adolescents

Primary Purpose

Obesity, Childhood

Status
Completed
Phase
Phase 1
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Endoscopic Sleeve Gastroplasty
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Childhood

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • New You Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adolescent Endosleeve

Arm Description

Patients who will undergo endoscopic sleeve gastroplasty

Outcomes

Primary Outcome Measures

Weight Loss
% total weight loss
Adverse events
Adverse events, including hospitalization, or unplanned intervention

Secondary Outcome Measures

Full Information

First Posted
December 16, 2018
Last Updated
May 4, 2019
Sponsor
King Saud University
Collaborators
New You Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03778697
Brief Title
Endosleeve in Adolescents
Official Title
Safety and Efficacy of Endoscopic Sleeve Gastroplasty in Obese Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University
Collaborators
New You Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adolescent Endosleeve
Arm Type
Experimental
Arm Description
Patients who will undergo endoscopic sleeve gastroplasty
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Sleeve Gastroplasty
Other Intervention Name(s)
Endosleeve
Intervention Description
Endoscopic full-thickness suture system to plicate the greater curvature of the stomach
Primary Outcome Measure Information:
Title
Weight Loss
Description
% total weight loss
Time Frame
One year
Title
Adverse events
Description
Adverse events, including hospitalization, or unplanned intervention
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aayed R Alqahtani, MD FRCSC FACS
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New You Medical Center
City
Riyadh
State/Province
Central Region
ZIP/Postal Code
11671
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31658128
Citation
Alqahtani A, Elahmedi M, Alqahtani YA, Al-Darwish A. Endoscopic Sleeve Gastroplasty in 109 Consecutive Children and Adolescents With Obesity: Two-Year Outcomes of a New Modality. Am J Gastroenterol. 2019 Dec;114(12):1857-1862. doi: 10.14309/ajg.0000000000000440.
Results Reference
derived

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Endosleeve in Adolescents

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