Clinical trial
Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM
Recruiting now · Not applicable · 1 countries · Registry ID NCT07660445
What this study is about
This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM
Basic eligibility
Full registry criteria
Treatments and study arms
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.
Primary outcomes
Changes of glucose lower drugs/ insulin dosage
Study locations
1 locations were listed when this page was built. The first 40 are shown.