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NCT Number: NCT07660445

Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

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

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Key information

Conditions

Obesity Type 2 Diabetes Mellitus

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, the Chinese University of Hong Kong

Shatin, Hong Kong

Location status: Recruiting

Location contact

Alice Kong, MD

SUB_INVESTIGATOR

Derek Xia, PhD(CUHK)

SUB_INVESTIGATOR

Ivy Poon

CONTACT

[email protected]

+85235052956

Jimmy Lai

SUB_INVESTIGATOR

Philip Chiu, MD

SUB_INVESTIGATOR

Raymond Tang, MD

SUB_INVESTIGATOR

Stephen Ng, FRCSEd(Gen)

CONTACT

[email protected]

+85235052956

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Diabetic medications

    Time frame: 12 months post-procedure

    Changes of glucose lower drugs/ insulin dosage

Secondary outcomes

  1. Total body weight loss (%TBWL)

    Time frame: 24 months post-procedure

    Percent total body weight loss (%TBWL) from baseline to Month 24

  2. Incidence of adverse events

    Time frame: within 30 days post-procedure

    Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)

  3. Body fat percentage

    Time frame: 24 months post-procedure

    Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 24

  4. Change in Quality of Life

    Time frame: 24 months post-procedure

    measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 24

  5. Faecal and duodenal microbiome

    Time frame: 12 months post-procedure

    changes in faecal microbiome from baseline to Month 12

  6. Improvement of MAFLD

    Time frame: 24 months post-procedure

    Proportion of subjects with improvement of liver steatosis and without worsening of fibrosis on liver histology

  7. HbA1c

    Time frame: 24 months post-procedure

    Change in HbA1c (%) from baseline to Month 24

Study contacts

Contact information is provided by the study sponsor or research team.

Ivy Study coordinator

CONTACT

[email protected]

+85235052956

Stephen Ng

CONTACT

[email protected]

+85235052956

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: DRAGON

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jun 22, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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