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RECRUITING
NCT06438510
NA

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

Ablation of the gastric fundus mucosa with hybrid argon plasma coagulation (HYBRIDAPC) in obese patients undergoing ESG could result in restoration of ghrelin cell function in the gastric fundus. This could improve long-term outcomes in terms of body weight loss and comorbidity reduction in obese patients undergoing ESG.

Official title: A Pilot Study to Evaluate the Impact of Gastric Mucosal Ablation (GMA) of the Fundus With Hybrid Argon Plasma Coagulation (HybridAPC) Combined With Endoscopic Sleeve Gastroplasty (ESG) on Obesity

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-10-08

Completion Date

2025-06-01

Last Updated

2024-06-03

Healthy Volunteers

No

Conditions

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.

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Italy