The Fulness Trial (Fundus mUcosaL abLation aNd Endoscopic Sleeve Gastroplasty)

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

October 8, 2023

Primary Completion Date

January 1, 2025

Study Completion Date

June 1, 2025

Conditions
Obesity
Interventions
PROCEDURE

Gastric Mucosal Ablation (GMA) of the fundus with Hybrid Argon Plasma Coagulation (HybridAPC) combined with Endoscopic Sleeve Gastroplasty (ESG)

All endoscopic procedures will be performed with the patient in the supine position, under general anesthesia, with endotracheal intubation, in CO2 using a flexible endoscopic suturing system (OverStitchTM; Apollo Endosurgery, Austin, TX, USA) connected to a dual-channel endoscope (GIF-2TH180 or GIF-2TH160; Olympus, Center Valley, PA, USA ). The HybridAPC with submucosal injection and APC will be delivered by ErbeJet®2. ESG will be obtained by placing full-thickness sutures in the body gastric wall, from the angulus to the gastric fundus. Biopsy tissue will be collected from the gastric fundus and the samples will be fixed for histopathologic examination. In the next step HybridAPC to the gastric mucosa of the fundus is applied.

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER