Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates

NARecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

September 24, 2023

Primary Completion Date

July 1, 2027

Study Completion Date

July 1, 2027

Conditions
Obesity, MorbidEnd Stage Renal DiseaseKidney TransplantationEndoscopic Sleeve Gastroplasty
Interventions
PROCEDURE

Endoscopic Sleeve Gastroplasty (ESG)

ESG will be performed under general anaesthesia with orotracheal intubation. The Endomina® suturing system (EndoTools Therapeutics S.A., Gosselies, Belgium) mounted on a single channel endoscope (GIF-H190/GIF-HQ190; Olympus Medical Systems Corp., Tokyo, Japan) will be used. This system allows to obtain full thickness gastric sutures through the gastric wall of the gastric body, leaving the antrum and the gastric fundus free. The ESG starts with the reduction of the gastric body, suturing from distal to proximal and starting from the notch of the angulus and ending at the level of the fundus. 4-8 full thickness stitches will be placed, with 2 passes per stitch. The final effect of ESG is the creation of a gastric tubule thus reducing the volume of the stomach. After the procedure, the final shape will be evaluated, to examine any gaps that would require additional closure, and to exclude bleedings and/or other complications.

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER