Endoscopic Sleeve Gastroplasty for Treatment of Obesity

Grupo Hospital de Madrid

Status: Unknown

Conditions: Obesity

Treatments: Procedure: Endoscopic sleeve gastroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02231970

657-GHM

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Endoscopic sleeve gastroplasty

Experimental group

Description:

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.

Treatment:

Procedure: Endoscopic sleeve gastroplasty