Post written by Benjamin Norton, MD, from Cleveland Clinic London, London, United Kingdom.

We are currently experiencing an obesity and diabetic epidemic. We know that the number of people living with type 2 diabetes (T2D) is expected to rise worldwide to alarming rates (1.31 billion by 2050).¹ We are seeing an explosion in the number of available pharmacotherapies for the treatment of T2D and obesity, but real-world access, discontinuation rates, and intolerance remain a major concern. We know a significant proportion of patients would benefit from a nondrug, nonsurgical intervention as an adjunct or alternative to continued medical therapy.

Consequently, metabolic endoscopy represents an exciting new field of gastrointestinal endoscopy, whereby devices are being developed to manipulate the metabolic signal derived from the proximal intestines. One of these procedures is duodenal mucosal ablation, which involves selective, reversible destruction of the abnormal and hypertrophied mucosal lining of the postampullary duodenum.

Until now, technologies have involved over-the-guidewire systems with the use of fluoroscopy to direct and position the devices within the duodenum. Therefore, there is an unmet need in making these procedures safer, easier, and hopefully more effective.

In our study, we aimed to assess the safety, tolerability, feasibility, and early efficacy of a novel through-the-scope technology that uses radiofrequency vapor ablation (RFVA) as a new modality for duodenal mucosal ablation. RFVA represents a simple and scalable endoscopic option for the treatment of patients with T2D.

T2D is a chronic complex metabolic disease that requires a multimodal approach to treatment with many pharmacological therapies, monitoring devices, dietary involvement, and surgical options. Over the last decade, nondrug, nonsurgical options for glycemic control in the form of metabolic endoscopic interventions have become increasingly investigated in clinical trials. Providing these types of interventions to patients is essential to improve access to care, especially among those who do not want to undergo invasive surgery or cannot tolerate modern pharmacotherapies.

In addition, emerging evidence that these types of endoscopic interventions may have a synergistic effect with new gut hormone—derived therapies is incredibly exciting. Therefore, we felt it imperative to assess whether RFVA, which is a simple, through-the-scope technology, could be a potential treatment option for patients living with T2D.

In our first-in-human study, we treated 27 patients with inadequately controlled T2D despite oral glucose-lowering agents. We showed that RFVA with our first-generation catheter was feasible in all patients with 100% technical success. The through-the-scope design means that vapor can be delivered accurately to the postampullary duodenal mucosa with precision and direct endoscopic control. The vapor itself is generated by saline passing over a bipolar electrode positioned within the lumen and at the distal tip of the catheter. We observed that RFVA was well-tolerated with low pain scores and no serious adverse events, and early efficacy showed an excellent reduction in glycated hemoglobin by -0.8% at 6 months without change in glucose-lowering agents or significant weight loss.

Because of the simplicity of the procedure, it became clear that extending the length of ablation was a real possibility. We hypothesized that a longer length of ablation could lead to a better and more durable reduction in glycemic hemoglobin. This is a concept not possible without a through-the-scope device.

Thus, we started to investigate the impact of a longer ablation length as part of a procedure known as proximal intestinal mucosal ablation with our second-generation RFVA mesh-tip catheter. We are delighted to say we should see the main results from our investigation in 2026. This is a very exciting time to be in the field of metabolic endoscopy!

Radiofrequency vapor ablation system with processor, foot pedal, and catheter (arrow points to catheter).

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1. Ong KL, Stafford LK, McLaughlin SA, et al. Global, regional, and national burden of diabetes from 1990 to 2021, with projections of prevalence to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet 2023;402:203-34. ↩︎