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pulsENDO procedure for type 2 diabetes and fatty liver disease

Tests the pulsENDO procedure in adults with type 2 diabetes and fatty liver.

Plain-language title generated from the registry record
Registry title: Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease

Key facts

Where
Shatin, Hong KongSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Source: NCT07390422, who can take part

Where in Hong Kong

  • Chinese University of Hong KongShatin, Hong KongTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Chinese University of Hong Kong
Trial code
NCT07390422
Record updated
15 September 2026
Original description
This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.Read full original descriptionShow less

Duodenal Recellularization Via Electroporation Therapy for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1 Study)

This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.

Inclusion: Duration of T2DM < 10 years; BMI 18.5-40kg/m2; Failure to achieve adequate HbA1c reduction (7.5 - 11%) after at least 3 months stable dosage of oral glucose lowering drugs.

Exclusion: Previous treatment with pulsENDO or similar procedure; Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO; Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet 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; 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; Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/microliter or known coagulopathy; Patients on insulin; 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.

ClinicalTrials.gov NCT07390422