Background

The ReCET is a novel, non-thermal approach for the re-cellularization of the duodenum with regenerated metabolically active cells using a pulsed electric field (PEF) for diabetes.

Methods

This is a multicenter prospective feasibility trial. Eligibility criteria include 22-65 years of age, on 2-3 non-insulin glucose-lowering medications, HbA1c 7.5%-10.0% and BMI 24-40 kg/m². The procedure involves endoscopic placement of the ReCET catheter and delivery of PEF to the duodenum (Figure 1). Patients are followed for 12 months with endoscopy at 4 weeks. The background medications are maintained stable. The primary endpoint is device/procedure-related serious adverse events (SAEs). Secondary endpoints include procedure success and glycemic parameters.

Results

Ten patients enrolled to date, with a mean age of 52.7 ± 9.4 years, 60% male, BMI 30.4 ± 4.1 kg/m², T2D duration 6.4 ± 2.2 years, and baseline HbA1c 8.4 ± 0.6%. Procedure success was 100%, and mean treatment length of the duodenum was 11.4 ± 2.8 cm. All patients were discharged on the same day. No device/procedure-related SAEs occurred. Mild sore throat was the only device/procedure-related AEs reported in 2/10 patients. Complete mucosal healing was observed at 4-week endoscopy with no stricture or other abnormal findings. Five patients have completed the 24-week follow-up, 4/5 had HbA1c ≤7.0%. Mean weight loss was 5.0% ± 3.8% at 24 weeks.

Conclusions

Application of PEF in duodenum using the ReCET device is technically feasible and safe. Observed glycemic improvement is promising and elucidates a novel adjunctive therapy with a unique mechanism of action. ClinicalTrials.gov NCT05014204