Introduction
The duodenum plays a key role in regulating metabolism and is known to be dysfunctional early in the development of metabolic diseases such as type 2 diabetes (T2D). Duodenal mucosal resurfacing (DMR) is a non-pharmacologic, investigational, endoscopic treatment designed to hydrothermally ablate the duodenal mucosa to restore the metabolic functionality of the duodenum in people with T2D. DMR has a CE mark, reimbursement in select medical centres in Germany, and has been evaluated in over 300 patients to date with favorable safety and metabolic benefits observed. As part of the currently enrolling, global, pivotal Revitalize 1 trial for DMR, competency-based training and implementation have evolved to support scalable education of advanced-endoscopist investigators.
Aims & Methods
Here, we describe the current endoscopist training program for DMR, demonstrate its alignment with the European Society of Gastrointestinal Endoscopy1 and the American Society for Gastrointestinal Endoscopy2 training and effectiveness principles, and provide evidence that training methodology for DMR has led to acceptable and consistent safety outcomes in Revitalize 1. The training program consists of three core elements designed to enhance advanced-endoscopist proficiency toward safe and efficacious execution of the DMR procedure:
1) Structured didactic overview of the DMR system, procedure, and core competencies;
2) Initial hands-on tracking of the DMR catheter through the validated DMR training simulator; and
3) Hands-on live-patient cases focused on the successful execution of the DMR procedure and demonstration of core competencies.
The DMR simulator was developed and validated to complement the didactic component of the training program and recapitulate endoscopy skills necessary to perform the procedure as intended. Successful training was defined as completion of the full program with demonstration of competency in core DMR skills and troubleshooting techniques using the simulator. Procedural success was defined as performing ablations along the anatomical length of the duodenum from immediately beyond the ampulla of Vater to the Ligament of Treitz, while minimizing longitudinal gaps between areas of ablated mucosa.
Results
The DMR training program has been used to train therapeutic endoscopists in 6 centres in the EU and US as investigators in Revitalize 1. All centres successfully completed training in ~3 hours within 2 weeks of the first case. Nine open-label patients have been treated, to date, with 100% procedural success rate. Baseline characteristics were consistent with uncontrolled T2D despite multiple glucose‑lowering medications and insulin: 66.7% male, median (min, max), age 60 (45, 68) years, HbA1c 8.5% (7.6%, 9.1%), weight 96 (85, 128) kg, and diabetes duration 13 (7, 24) years. Adverse events (AEs) definitely or probably related to the device and/or procedure included sore throat (n=2), abdominal bloating (n=1), and abdominal pain (n=1). AEs were mild and resolved without sequalae. No observed long-term device- or procedure-related AEs, no device- or procedure-related SAEs, and no unanticipated AEs have been observed to date.
Conclusion
The three core elements of the DMR training program, inclusive of the DMR simulator, are scalable and have been reproducibly employed to train advanced therapeutic endoscopists to safely perform the DMR procedure. Results thus far suggest that DMR appears to be a safe, broadly accessible, and disease‑modifying approach to treat metabolic disease, such as T2D, via therapeutic endoscopy.
References
1Boškoski et al. Curriculum for bariatric endoscopy and endoscopic treatment of the complications of bariatric surgery: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2023 Mar;55(3):276-293.
2Yang et al. The status of training in new technologies in advanced endoscopy: from defining competence to credentialing and privileging. Gastrointest Endosc. 2020 Nov;92(5):1016-1025.
Disclosure
IB: consultant–Apollo Endosurgery, Boston Scientific, Cook Medical, ERBE Elektromedizin; lecturer–Boston Scientific, Cook Medical, Microtech; grants–Apollo Endosurgery, Erbe Elektromedizin. CG: speaker–Intuitive Surgical (Proctor), BD, WL Gore, Medtronic. JV: consultant–Boston Scientific, Aspero Medical; research funding–Olympus America. MAG: research support/contracted research–Olympus America, Fractyl, Allurion Technologies; Consultant–Boston Scientific, Ambu. ES, KW, and HR: employees and shareholders of Fractyl Health, Inc. RS: Boston Scientific, Cook Medical, Intuitive Surgical.
