Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

NCT07660445 | Recruiting

• 1 other identifier: CRE-2026.033
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in Diabetic medications

  Changes of glucose lower drugs/ insulin dosage

  12 months post-procedure

Secondary Outcomes (7)

• Total body weight loss (%TBWL)

  24 months post-procedure

• Incidence of adverse events

  within 30 days post-procedure

• Body fat percentage

  24 months post-procedure

• Change in Quality of Life

  24 months post-procedure

• Faecal and duodenal microbiome

  12 months post-procedure

Study Arms (1)

ESG plus duodenal pulsENDO

EXPERIMENTAL

ESG and pulsENDO procedure will be performed in same session

Procedure: Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO)

Interventions

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.

ESG plus duodenal pulsENDO

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, the Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

Study Officials

• Stephen Ng

  Prince of Wales Hospital, the Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Ng

CONTACT

+85235052956; stephenng@surgery.cuhk.edu.hk

Ivy Study coordinator

CONTACT

+85235052956; ivypoon@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2031
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

HK (1)