Endoscopic Sleeve Gastroplasty for Treatment of Obesity

Not Applicable

• Conditions: Obesity
• Interventions: Procedure: Endoscopic sleeve gastroplasty

• Registration Number: NCT02231970
• Lead Sponsor: Grupo Hospital de Madrid

Brief Summary

Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy.

The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity

Detailed Description

The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up by a nutritionist and a psychologist weekly.The outcome assessment included: change in body weight, percentage of loss of excess body weight and adverse effects

Study Timeline

• Status Verified: 2014-09
• Study Start: 2014-09
• Study First Submitted: 2014-09-01
• Study First Submitted QC: 2014-09-01
• Study First Posted: 2014-09-04
• Last Update Submitted: 2014-09-04
• Last Update Posted: 2014-09-05
• Primary Completion: 2015-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Obesity Willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year -

Exclusion Criteria

Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) Coagulopathy Psychiatric disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic sleeve gastroplasty	Endoscopic sleeve gastroplasty	The intervention is an endoscopic procedure: to perform endoscopic sleeve gastroplasty we used a cap-based flexible endoscopic suturing system (OverStitch™, Apollo, Inc. Austin, Texas) mounted on a double-channel endoscope (GIF-2T160; Olympus Medical Systems Corporation, Tokyo, Japan) to achieve full-thickness, running sutures through the gastric wall from antrum to fundus.

Primary Outcome Measures

Name	Time	Method
Change in body weight	One year

Secondary Outcome Measures

Name	Time	Method
Safety	One year	Any complications following the intervention like abdominal pain or bleeding

Trial Locations

Locations (1)

Hospital Universitario Sanchinarro; 🇪🇸 Madrid, Spain