Endoscopic Sleeve Gastroplasty for Treatment of Obesity

NCT ID: NCT02231970

Last Updated: 2014-09-05

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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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

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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

Conditions

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Obesity

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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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.

Group Type EXPERIMENTAL

Endoscopic sleeve gastroplasty

Intervention Type PROCEDURE

To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty

Interventions

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Endoscopic sleeve gastroplasty

To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty

Intervention Type PROCEDURE

Other Intervention Names

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ESG

Eligibility Criteria

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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

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Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Grupo Hospital de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Sofia Perea, Director Clinical Trials Unit.

Director, Clinical Trial Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GONTRAND LOPEZ-NAVA, MD

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL UNIVERSITARIO SANCHINARRO

Locations

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Hospital Universitario Sanchinarro

Madrid, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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GONTRAND LOPEZ-NAVA, MD

Role: CONTACT

+34917567800

INMACULADA BAUTISTA-CASTAÑO, MD, PHD

Role: CONTACT

+34917567800

Other Identifiers

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657-GHM

Identifier Type: -

Identifier Source: org_study_id

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