NCT07376486

Brief Summary

This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
71mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Mar 2026Feb 2032

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2030

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2032

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

January 22, 2026

Last Update Submit

January 22, 2026

Conditions

Diabete MellitusT2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)

Outcome Measures

Primary Outcomes (1)

  • HbA1c ≤6.5% without glucose lowering drugs

    Proportion of participants with HbA1c ≤6.5% without glucose lowering drugs

    6 months post-procedure

Secondary Outcomes (6)

  • HbA1c

    24 months post-procedure

  • Total body weight loss (%TBWL)

    24 months post-procedure

  • Incidence of adverse events

    within 30 days post-procedure

  • Body fat percentage

    24 months post-procedure

  • Change in Quality of Life

    24 months post-procedure

  • +1 more secondary outcomes

Study Arms (1)

Endoscopic duodenal recellularization via electroporation therapy (ReCET)

EXPERIMENTAL

ReCET procedure entails the ablation of the duodenal mucosa with irreversible electroporation (IRE)

Procedure: ReCET treatment

Interventions

ReCET treatmentPROCEDURE

The ReCET procedure utilizes the ReCET 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.

Endoscopic duodenal recellularization via electroporation therapy (ReCET)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Duration of T2DM \</= 2 years
  • HbA1c \</= 7.5%
  • On 0-1 oral diabetes medications

You may not qualify if:

  • Previous treatment with ReCET or similar procedure
  • Previous GI surgery that could preclude the ability to perform ReCET, or acute gastric and duodenal pathology that increased the risk of ReCET
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Diabetes MellitusNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesFatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Stephen Ng, FRCSEd(Gen)

    Prince of Wales Hospital, the Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Ng, FRCSEd(Gen)

CONTACT

+85235052956stephenng@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 30, 2030

Study Completion (Estimated)

February 28, 2032

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

HK(1)