Endoscopic Sleeve Gastroplasty for Treatment of Obesity

September 4, 2014 updated by: Sofia Perea, Director Clinical Trials Unit., Grupo Hospital de Madrid

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28050
        • Recruiting
        • Hospital Universitario Sanchinarro
        • Principal Investigator:
          • GONTRAND LOPEZ-NAVA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Endoscopic sleeve gastroplasty
To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty
Other Names:
  • ESG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: One year
Any complications following the intervention like abdominal pain or bleeding
One year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of excess weight loss
Time Frame: One year
Percentage of excess weight loss defined as the percentage of weight loss in relation with initial weight minus weight at BMI of 25 kg/m2
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Hospital de Madrid

Investigators

  • Principal Investigator: GONTRAND LOPEZ-NAVA, MD, Hospital Universitario Sanchinarro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

September 1, 2014

First Submitted That Met QC Criteria

September 1, 2014

First Posted (Estimate)

September 4, 2014

Study Record Updates

Last Update Posted (Estimate)

September 5, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 657-GHM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Endoscopic sleeve gastroplasty

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe