Trials / Not Yet Recruiting
Not Yet RecruitingNCT07390422
Duodenal ReCET for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease
Duodenal Recellularization Via Electroporation Therapy for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1 Study)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Chinese University of Hong Kong · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the efficacy, safety, and mechanisms of ReCET procedure in patients with T2DM and its effect on MASLD.
Detailed description
This is a prospective, single-arm feasibility study enrolling individuals with type 2 diabetes mellitus (T2DM) who have failed to achieve adequate glycemic control with oral glucose-lowering medications. Participants will undergo the ReCET procedure and liver biopsies both prior to and after the procedure to evaluate its effects on metabolically associated fatty liver disease (MAFLD). They will be followed for 12 months to assess the primary endpoint and for a total of 2 years. Participants are permitted to undergo a repeat ReCET procedure once if they initially respond but experience a recurrence of suboptimal diabetes management between 1 and 2 years after the procedure. They will be followed up for an additional year after the repeated procedure.
Conditions
- T2DM (Type 2 Diabetes Mellitus)
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
- Metabolic Syndrome (MetS)
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | ReCET treatment | 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. |
Timeline
- Start date
- 2026-04-01
- Primary completion
- 2031-03-31
- Completion
- 2033-03-31
- First posted
- 2026-02-05
- Last updated
- 2026-02-05
Locations
1 site across 1 country: Hong Kong
Source: ClinicalTrials.gov record NCT07390422. Inclusion in this directory is not an endorsement.