Endosleeve in Adolescents

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2019-05-04

Brief Summary

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

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Detailed Description

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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.

Conditions

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Obesity, Childhood

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adolescent Endosleeve

Patients who will undergo endoscopic sleeve gastroplasty

Group Type EXPERIMENTAL

Endoscopic Sleeve Gastroplasty

Intervention Type PROCEDURE

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

Interventions

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Endoscopic Sleeve Gastroplasty

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

Intervention Type PROCEDURE

Other Intervention Names

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Endosleeve

Eligibility Criteria

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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