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Recruiting NCT07660445

Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

No phase Interventional Obesity Type 2 Diabetes Mellitus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO).
Who it may be relevant to
Registry conditions: Obesity Type 2 Diabetes Mellitus. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • 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 : ES

Primary outcome measures

  • Change in Diabetic medications [Time frame: 12 months post-procedure]
Secondary outcome measures (7)
  • Total body weight loss (%TBWL) [Time frame: 24 months post-procedure]
  • Incidence of adverse events [Time frame: within 30 days post-procedure]
  • Body fat percentage [Time frame: 24 months post-procedure]
  • Change in Quality of Life [Time frame: 24 months post-procedure]
  • Faecal and duodenal microbiome [Time frame: 12 months post-procedure]
  • Improvement of MAFLD [Time frame: 24 months post-procedure]
  • HbA1c [Time frame: 24 months post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Prince of Wales Hospital, the Chinese University of Hong Kong — Shatin

Identifiers

NCT: NCT07660445 · CRE-2026.033

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗