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Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM
Sponsor: Chinese University of Hong Kong
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
Conditions
Interventions
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