NCT03778697

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 16, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

December 16, 2018

Last Update Submit

May 4, 2019

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (2)

  • Weight Loss

    % total weight loss

    One year

  • Adverse events

    Adverse events, including hospitalization, or unplanned intervention

    One year

Study Arms (1)

Adolescent Endosleeve

EXPERIMENTAL

Patients who will undergo endoscopic sleeve gastroplasty

Procedure: Endoscopic Sleeve Gastroplasty

Interventions

Endoscopic Sleeve GastroplastyPROCEDURE

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

Also known as: Endosleeve
Adolescent Endosleeve

Eligibility Criteria

Age10 Years - 21 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Age \<10 years
  • Age \>21 years
  • Presence of large hiatal hernia
  • Previous gastric surgery
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New You Medical Center

Riyadh, Central Region, 11671, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 31658128DERIVED

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aayed R Alqahtani, MD FRCSC FACS

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery, Director of Obesity Chair

Study Record Dates

First Submitted

December 16, 2018

First Posted

December 19, 2018

Study Start

December 1, 2017

Primary Completion

April 30, 2019

Study Completion

May 4, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)