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Hydrothermal duodenal mucosal resurfacing: a novel procedural therapy for metabolic disease

      This video demonstrates Revita duodenal mucosal resurfacing (DMR; Fractyl Laboratories, Inc, Waltham, Mass), an investigational, catheter-based, upper endoscopic procedure for the treatment of metabolic diseases, including type 2 diabetes (T2D) and nonalcoholic steatohepatitis (Video 1, available online at www.VideoGIE.org). The procedure uses hydrothermal ablation of approximately 10 cm of duodenal mucosa to elicit beneficial metabolic effects, including improvements in hyperglycemia in patients with T2D who are suboptimally controlled on oral antidiabetic medications. This video provides an overview of the procedure and describes the 6-month clinical results of a 43-year-old man (duration of T2D, 6 years) treated with DMR. At screening, the patient had a body mass index of 31, weight of 91.6 kg, hemoglobin A1c of 9.5%, and fasting plasma glucose (FPG) of 162 mg/dL. Six months after a single hydrothermal DMR procedure, the patient’s hemoglobin A1c had fallen to 7.2% and FPG had fallen to 132 mg/dL. The patient experienced a modest weight reduction (–2.3 kg), and his use of oral antidiabetic medications (n = 2) did not change. Liver enzymes, followed as a safety signal, remained normal. Follow-up endoscopy at 90 days indicated full mucosal healing. Figure 1 depicts the duodenal mucosa (A) after saline solution lift and (B) after ablation. We conclude that DMR may provide the ability to improve hyperglycemia in T2D and may offer a novel nonpharmacologic treatment of metabolic disease. Further study is needed to evaluate the long-term safety, efficacy, and durability of this procedure.
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      Figure 1Images from a 43-year-old man with type 2 diabetes who underwent hydrothermal double mucosal resurfacing. During the procedure, the duodenum is sized and (A) the mucosa is lifted circumferentially. Mucosal lifting is followed by hydrothermal ablation of the mucosa (B) to stimulate regeneration.

      Disclosure

      The following authors disclosed financial relationships relevant to this publication: M. Galvao Neto: Scientific advisory board member and research support recipient from GI Dynamics, Inc and Fractyl Laboratories, Inc; L. Rodriguez and P. Becerra: Research support recipients from Fractyl Laboratories, Inc; S. Mani: Full-time employee of Fractyl Laboratories, Inc, manufacturer of the investigational device; R. Rothstein: Research support recipient from Covidien and BaroNova; scientific advisor for Allurion; consultant for Boston Scientific and Fractyl Laboratories; and Data and Safety Monitoring Board member for Takeda. Research support for this study was provided by Fractyl Laboratories, Inc, manufacturer of the Revita DMR device to M. Galvao Neto, L. Rodriguez, and P. Becerra.

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