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This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM
This is a prospective, single-armed, feasibility study enrolling individuals with obesity and type 2 diabetes. Participants will be followed for a total of 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESG plus duodenal pulsENDO | Experimental | ESG and pulsENDO procedure will be performed in same session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetic medications | Changes of glucose lower drugs/ insulin dosage | 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Total body weight loss (%TBWL) | Percent total body weight loss (%TBWL) from baseline to Month 24 | 24 months post-procedure |
| Incidence of adverse events | Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Ng | Contact | +85235052956 | stephenng@surgery.cuhk.edu.hk | |
| Ivy Study coordinator | Contact | +85235052956 | ivypoon@surgery.cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Ng | Prince of Wales Hospital, the Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, the Chinese University of Hong Kong | Recruiting | Shatin | Hong Kong |
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| within 30 days post-procedure |
| Body fat percentage | Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24 | 24 months post-procedure |
| Change in Quality of Life | measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 24 | 24 months post-procedure |
| Faecal and duodenal microbiome | changes in faecal microbiome from baseline to Month 12 | 12 months post-procedure |
| Improvement of MAFLD | Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology | 24 months post-procedure |
| HbA1c | Change in HbA1c (%) from baseline to Month 24 | 24 months post-procedure |