NCT07376486 Duodenal pulsENDO as an Early Treatment for Type 2 DM
| NCT ID | NCT07376486 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Diabete Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2031-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-09-01 with a primary completion date of 2031-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).
Eligibility Criteria
Inclusion Criteria: * Duration of T2DM \</= 2 years * HbA1c \</= 7.5% * On 0-1 oral diabetes medications Exclusion Criteria: * 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 * Type I 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 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 * 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 * 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
Contact & Investigator
Stephen Ng, FRCSEd(Gen)
PRINCIPAL INVESTIGATOR
Prince of Wales Hospital, the Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT07376486 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Diabete Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07376486 currently recruiting?
Yes, NCT07376486 is actively recruiting participants. Contact the research team at stephenng@surgery.cuhk.edu.hk for enrollment information.
Where is the NCT07376486 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT07376486 clinical trial?
NCT07376486 is sponsored by Chinese University of Hong Kong. The principal investigator is Stephen Ng, FRCSEd(Gen) at Prince of Wales Hospital, the Chinese University of Hong Kong. The trial plans to enroll 40 participants.