Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM (DRAGON)

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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity Type 2 Diabetes Mellitus
• Intervention / Treatment: Procedure: Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen Ng; Phone Number: +85235052956; Email: stephenng@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Ivy Study coordinator; Phone Number: +85235052956; Email: ivypoon@surgery.cuhk.edu.hk

Study Locations

• Hong Kong
  • Shatin, Hong Kong
    • Recruiting
    • Prince of Wales Hospital, the Chinese University of Hong Kong
    • Contact: Stephen Ng, FRCSEd(Gen); Phone Number: +85235052956; Email: stephenng@surgery.cuhk.edu.hk
    • Sub-Investigator: Alice Kong, MD
    • Sub-Investigator: Raymond Tang, MD
    • Sub-Investigator: Derek Xia, PhD(CUHK)
    • Contact: Ivy Poon; Phone Number: +85235052956; Email: ivypoon@surgery.cuhk.edu.hk
    • Sub-Investigator: Philip Chiu, MD
    • Sub-Investigator: Jimmy Lai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• BMI >/= 27kg/m2
• Known T2DM
• Individualized Metabolic Surgery (IMS) score 25-115
• HbA1c <11% (subjects on oral glucose lowering drug(s) or HbA1c <8% (subjects on insulin)

Exclusion Criteria:

• Previous treatment with ReCET, ESG or similar procedure
• Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET or ESG
• Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis
• Fasting C-peptide level <0.5ug/L
• Any inflammatory disease of the gastrointestinal tract such as Crohn's disease
• Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study
• Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy
• Currently taking prescription antithrombotic therapy (e.g., anticoagulant agent) within 10 days prior to study and/or there is a need or expected need to use during the study period
• Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)
• Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month
• Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.
• Patients with contra-indications to endoscopy
• Patients with cirrhosis due to causes other than MASLD
• Malignancy
• Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
• Pregnant or breast feeding
• ASA grade IV & V
• Mental or psychiatric disorder; Drug or alcohol addiction
• Other cases deemed by the examining physician as unsuitable for safe treatment
• Refusal to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ESG plus duodenal pulsENDO; ESG and pulsENDO procedure will be performed in same session

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diabetic medications	Changes of glucose lower drugs/ insulin dosage	12 months post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c (%) from baseline to Month 24	24 months post-procedure
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)	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Stephen Ng, Prince of Wales Hospital, the Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2031

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 20, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CRE-2026.033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No