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Endoscopic Sleeve Gastroplasty for Treatment of Obesity

Primary Purpose

Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Endoscopic sleeve gastroplasty

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Endoscopic sleeve gastroplasty, Weight loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hospital Universitario SanchinarroRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic sleeve gastroplasty

Arm 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.

Outcomes

Primary Outcome Measures

Change in body weight

Secondary Outcome Measures

Safety

Any complications following the intervention like abdominal pain or bleeding

Full Information

NCT ID

NCT02231970

First Posted

September 1, 2014

Last Updated

September 4, 2014

Sponsor

Grupo Hospital de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT02231970

Brief Title

Endoscopic Sleeve Gastroplasty for Treatment of Obesity

Official Title

Endoscopic Sleeve Gastroplasty for Treatment of Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Grupo Hospital de Madrid

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

Keywords

Obesity, Endoscopic sleeve gastroplasty, Weight loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic sleeve gastroplasty

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Endoscopic sleeve gastroplasty

Other Intervention Name(s)

ESG

Intervention Description

To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty

Primary Outcome Measure Information:

Title

Change in body weight

Time Frame

One year

Secondary Outcome Measure Information:

Title

Safety

Description

Any complications following the intervention like abdominal pain or bleeding

Time Frame

One year

Other Pre-specified Outcome Measures:

Title

Percentage of excess weight loss

Description

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

Time Frame

One year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

GONTRAND LOPEZ-NAVA, MD

Phone

+34917567800

gontrandlopeznava@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

INMACULADA BAUTISTA-CASTAÑO, MD, PHD

Phone

+34917567800

inmaculadabautista60@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GONTRAND LOPEZ-NAVA, MD

Organizational Affiliation

HOSPITAL UNIVERSITARIO SANCHINARRO

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

GONTRAND LOPEZ-NAVA, MD

12. IPD Sharing Statement

Learn more about this trial

Endoscopic Sleeve Gastroplasty for Treatment of Obesity

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