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NCT07660445Recruiting

Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM

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

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
20 (estimated)
First submitted
16 Jun 2026
Start date
1 Sept 2026
Primary completion date
31 Jul 2029
Lead sponsor
Chinese University of Hong Kong
NCT number
NCT07660445

What you commit to

  • Study type: Interventional
  • Planned participants: 20
  • From 1 Sept 2026 to the primary completion date, 31 Jul 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • 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

Other illness

  • Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis
  • 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
  • Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.
  • Malignancy
  • Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)
  • Mental or psychiatric disorder; Drug or alcohol addiction

Lab values

  • Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy

Other

  • Fasting C-peptide level \<0.5ug/L
  • Patients with contra-indications to endoscopy
  • Patients with cirrhosis due to causes other than MASLD
  • Pregnant or breast feeding
  • ASA grade IV \& V
  • Other cases deemed by the examining physician as unsuitable for safe treatment
  • Refusal to participate

Who the study is looking for

  • 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)

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Prince of Wales Hospital, The Chinese University of Hong Kong
Coordinator of this site? Confirm its status
ShatinHong Kong SAR ChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.