ArticleiGIE : innovation, investigation and insights2025
Radiofrequency vapor ablation for duodenal mucosal ablation in the treatment of type 2 diabetes: results from the first-in-human pilot study.
Article in iGIE : innovation, investigation and insights, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05887635 (A Pilot Human Investigation of the Safety, Tolerability and Effectiveness of the Aqua Medical Circumferential RF Vapor), which is not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pilot Human Investigation of the Safety, Tolerability and Effectiveness of the Aqua Medical Circumferential RF Vapor (RFV) Ablation System for Duodenal Mucosal Ablation for the Management of Type-2 Diabetes Mellitus (STEAM T-2DM Pilot)
Who cites it
1 citing paper in PubMed.
- Endoscopy for Metabolic Diseases.Journal of clinical medicine · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
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.).
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.