In this first-in-human pilot trial, Norton, Papaefthymiou, Telese, Vignolo, Rodriguez Grunert, and Haidry explored radiofrequency vapor ablation (RFVA) as a minimally invasive endoscopic treatment for poorly controlled type 2 diabetes. The through-the-scope device delivers circumferential thermal vapor to the duodenal mucosa, aiming to replicate some of the metabolic benefits seen with bariatric surgery.
Across 27 patients, RFVA achieved 100% technical success, was well tolerated (peak pain score just 1.4), and caused no serious adverse events. Early data suggested modest HbA1c reductions at 4, 12, and 24 weeks, with full mucosal healing seen on biopsy by one month. While the trial was not powered for efficacy, the findings highlight RFVA’s procedural simplicity and safety, positioning it as a promising candidate in the growing field of metabolic endoscopy.