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Endoscopy
Endoscopy
10.1055/s-00000012
Endoscopy
Endoscopy
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38959971
10.1055/a-2344-7002
E-Videos-2023-12-4644-EV
E-Videos
First clinical application of a novel duodenal mucosal ablation device for type 2 diabetes using radiofrequency vapor ablation
http://orcid.org/0000-0002-3563-4973
Papaefthymiou Apostolis Dr.
http://orcid.org/0000-0003-2058-3162
Norton Benjamin Dr.
Hoebel Pablo Becerra Dr.
Rodriguez Grunert Leonardo Dr.
Haidry Rehan J. MD
1 591481 Gastroenterology, Cleveland Clinic London, London, United Kingdom of Great Britain and Northern Ireland
2 Clinica Colonial, Santiago, Chile
Correspondence Rehan J. Haidry, MD Cleveland Clinic London33 Grosvenor PlLondon SW1X 7HYUnited Kingdomhaidryr@ccf.org
03 7 2024
12 2024
1 7 2024
56 Suppl 1 E563E564
The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/).
2024
The Author(s).
https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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pmc Duodenal mucosal ablation is an emerging endoscopic technique for the management of metabolic diseases, providing promising results for the control of type 2 diabetes 11 22 . The continuous advancement of endoscopic devices aims to optimize procedural efficacy, operability, and scalability 33 .

A novel through-the-scope ablation device, the circumferential radiofrequency vapor ablation system (Aqua Medical, Pleasanton, California, USA), is currently under evaluation in a first-in-human clinical trial (NCT05887635). This device consists of a 10.5-Fr through-the-scope catheter-based system with an ablation segment 2.5 cm in length ( Fig. 1Fig. 1 ). Energy is delivered to the duodenal mucosa in the form of heated water vapor generated within the catheter tip using radiofrequency. Positioning discs attached to the tip direct the distribution of vapor to the targeted duodenal tissue and allow circumferential mucosal ablation.

Fig. 1 Fig. 1 Circumferential radiofrequency vapor ablation (RFVA) system.

We present the case of a patient with poorly controlled type 2 diabetes who was eligible for recruitment and underwent the procedure under general anesthesia, using a double-channel endoscope ( Video 1Video 1 ). The patient was on metformin and had a fasting blood glucose level of 127 mg/dL and HbA1c of 8.3%. The duodenal mucosa was initially reviewed and washed with 2% N-acetylcysteine solution, and the fluid was suctioned. The ampulla was identified, representing the landmark of the proximal end of the area to be treated, and marked by deploying a clip on the contralateral wall. The first ablation was delivered immediately distal to the clip, and subsequent ablations were performed in a proximal-to-distal direction with minimal overlap. After the first series of ablations, the mucosa was reviewed, and a second series of ablations was carried out over the initial treatment zone ( Fig. 2Fig. 2 ). Finally, the entire ablated segment was reviewed for complications and remaining nonablated segments. The patient was monitored for 24 hours post-procedure and remained asymptomatic. No adverse events were recorded prior to discharge. Follow-up after 1 month confirmed the absence of adverse events and a reduction in fasting blood glucose (118 mg/dl) and HbA1c (6.5%) levels.

Demonstration of the use of the novel duodenal mucosal ablation device using radiofrequency vapor ablation (RFVA) in a patient with type 2 diabetes.

Video 1

Video 1

Fig. 2 Fig. 2 Treatment zones in the duodenum for duodenal mucosal ablation.

This new circumferential radiofrequency vapor ablation system for duodenal mucosal ablation presents a promising intervention for type 2 diabetes. Results from the first-in-human STEAM T-2DM trial will provide insights into the overall safety and efficacy of this technique.

Endoscopy_UCTN_Code_TTT_1AO_2AN

Endoscopy E-Videos https://eref.thieme.de/e-videos

E-Videos is an open access online section of the journal Endoscopy , reporting on interesting cases and new techniques in gastroenterological endoscopy. All papers include a high-quality video and are published with a Creative Commons CC-BY license. Endoscopy E-Videos qualify for HINARI discounts and waivers and eligibility is automatically checked during the submission process. We grant 100% waivers to articles whose corresponding authors are based in Group A countries and 50% waivers to those who are based in Group B countries as classified by Research4Life (see: https://www.research4life.org/access/eligibility/ ). This section has its own submission website at https://mc.manuscriptcentral.com/e-videos .

Conflict of Interest R.J.H. has received research grants and funding from Pentax Medical, Apollo Endosurgery, Medtronic, Odin vision, Cook Endoscopy, Fractyl, Aqua medical, and Endogastric solutions. P.B.H. and L.R.G. have received research grants from Aqua Medical. A.P. and B.N. have nothing to declare.
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References

1 de Oliveira GHP de Moura DTH Funari MP Metabolic effects of endoscopic duodenal mucosal resurfacing: a systematic review and meta-analysis Obes Surg 2021 31 1304 1312 10.1007/s11695-020-05170-3 33417100
2 Mingrone G van Baar AC Devière J Safety and efficacy of hydrothermal duodenal mucosal resurfacing in patients with type 2 diabetes: the randomised, double-blind, sham-controlled, multicentre REVITA-2 feasibility trial Gut 2022 71 254 264 33597157
3 Haidry RJ van Baar AC Galvao NMP Duodenal mucosal resurfacing: proof-of-concept, procedural development, and initial implementation in the clinical setting Gastrointest Endosc 2019 90 673 68100 30935932
