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RECRUITING
NCT07660445
NA

Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM

Official title: Integrating Duodenal Recellularization Via Electroporation Therapy and Endoscopic Sleeve Gastroplasty as a Novel Approach to Managing Diabesity (DRAGON Study)

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-08-01

Completion Date

2031-07-31

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

PROCEDURE

Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO)

First part - pulsENDO procedure : The pulsENDO procedure utilizes the pulsENDO catheter to deliver non-thermal pulsed electric field to the duodenum to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum under endoscopic visualisation, starting from D4 and repeated proximally. Approximately 10-18 cm of axial length of the duodenum is treated. Second part - Endoscopic sleeve gastroplasty : ESG is performed using an endoscopic suturing device (Overstitch, BSC) to reduce the stomach volume through the creation of a restrictive endoscopic sleeve. This is accomplished with around 4-7 permanent full thickness sutures over greater curve stomach in a running plication extending from the angular incisura and continuing proximally with fundal sparing.

Locations (1)

Prince of Wales Hospital, the Chinese University of Hong Kong

Shatin, Hong Kong