Endosleeve in Adolescents | NCT03778697

Studies
Endosleeve in Adolescents

NCT03778697

Sponsor

King Saud University

Status

Completed

Last Update Posted

May 7, 2019Actual

Enrollment

100Actual

Phase

Phase 1Phase 2

Conditions

Obesity, Childhood

Interventions

Endoscopic Sleeve Gastroplasty

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

May 4, 2019Actual

First Submitted Date

Dec 16, 2018

First Submission Date that Met QC Criteria

Dec 16, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2019

Last Update Posted Date

May 7, 2019Actual

Name	Class
New You Medical Center	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Adolescent Endosleeve	Experimental	Patients who will undergo endoscopic sleeve gastroplasty	Procedure: Endoscopic Sleeve Gastroplasty

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic Sleeve Gastroplasty	Procedure	Endoscopic full-thickness suture system to plicate the greater curvature of the stomach	Adolescent Endosleeve

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aayed R Alqahtani, MD FRCSC FACS	King Saud University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New You Medical Center		Riyadh	Central Region	11671	Saudi Arabia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31658128	Derived	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.

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders