Radiofrequency vapor ablation for duodenal mucosal ablation in the treatment of type 2 diabetes: results from the first-in-human pilot study

Abstract

Background and Aims

Duodenal mucosal ablation (DMA) is an emerging endoscopic treatment modality for type 2 diabetes (T2D). The radiofrequency vapor ablation (RFVA) system (Aqua Medical Inc, Pleasanton, Calif, USA) is a single-use, through-the-scope, circumferential ablation catheter under investigation for DMA. In this pilot study, we assessed the safety, tolerability, procedural feasibility, and initial efficacy of RFVA.

Methods

We conducted a first-in-human, prospective, single-center trial enrolling 27 patients with poorly controlled T2D (glycated hemoglobin [HbA1c], 7.5%-10%) despite ≥1 oral antidiabetic drug. DMA was performed with the patient under anesthesia in several dose titrations as follows: safety cohort (180 J once, n = 2), first treatment cohort (180 J twice, n = 11), and second treatment cohort (200 J twice; n = 14). Primary outcomes were safety (number of serious adverse events [SAEs]), tolerability (based on a visual analog scale [VAS] pain score), feasibility (procedure time), and initial efficacy (change in HbA1c at 4, 12, and 24 weeks).

Results

Twenty-seven patients with a mean T2D duration of 6 years (standard deviation [SD], 2.6) underwent DMA with 100% technical success. Mean patient age was 54 years (SD, 6.6), 48% were men, and baseline HbA1c was 8.6% (SD, 0.6). Mean procedure time was 49.7 minutes (SD, 14.3) and catheter time 34.5 minutes (SD, 10.9). There were no SAEs, and the maximum mean VAS pain score was 1.4 (SD, 2.1) on day 2. We observed a change in HbA1c at 4 weeks (–0.9%), 12 weeks (–1.2%), and 24 weeks (–0.8%) after the procedure.

Conclusions

DMA using the RFVA system is a simple through-the-scope procedure that appears safe, well tolerated, and feasible for the treatment of T2D. (Clinical trial registration number: NCT05887635.)