Endoscopic Sleeve Gastroplasty for Treatment of Obesity

Obesity Clinical Trial

Official title:

Endoscopic Sleeve Gastroplasty for Treatment of Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02231970
• Other study ID #: 657-GHM
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2014
• Last updated: September 4, 2014
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2014
• Source: Grupo Hospital de Madrid
• Contact: GONTRAND LOPEZ-NAVA, MD
• Phone: +34917567800
• Email: gontrandlopeznava[@]gmail.com
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Endoscopic sleeve gastroplasty
To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty

Locations

Country	Name	City	State
Spain	Hospital Universitario Sanchinarro	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Grupo Hospital de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of excess weight loss	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	Yes
Primary	Change in body weight		One year	Yes
Secondary	Safety	Any complications following the intervention like abdominal pain or bleeding	One year	Yes