Clinical Trials Directory

Trials / Completed

CompletedNCT02948621

Endoscopic Sleeve Gastroplasty

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
IHU Strasbourg · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

The endoscopic sleeve gastroplasty allows stomach size reduction through an endoluminal suture approach without any incision. It could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement. The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity.

Detailed description

Gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. Nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. This could reduce the complications associated with current surgical techniques while obtaining the target gastric restriction, weight loss, comorbidities and quality of life improvement. The primary objective of this study is to assess weight loss after endoscopic sleeve gastroplasty in patients with morbid obesity according to the technique described in the literature: reduction of the gastric pouch into a sleeve structure by modification of the stomach greater curvature thanks to a plication.

Conditions

Interventions

TypeNameDescription
PROCEDUREEndoscopic sleeve gastroplastyEndoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.

Timeline

Start date
2016-10-01
Primary completion
2018-05-01
Completion
2020-05-01
First posted
2016-10-28
Last updated
2024-01-08

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02948621. Inclusion in this directory is not an endorsement.