RecruitingNot ApplicableNCT07660445

Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

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

Sponsor

Chinese University of Hong Kong

Enrollment

20 participants

Start Date

Sep 1, 2026

Study Type

INTERVENTIONAL

Conditions

Obesity Type 2 Diabetes Mellitus

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy for people with obesity type 2 diabetes mellitus. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREEndoscopic 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.