duodenal mucosal resurfacing trial

Duodenal Mucosal Resurfacing (DMR) | Mayo Clinic Connect Endoscopic duodenal mucosal resurfacing is a single minimally invasive procedure that involves circumferential hydrothermal ablation of the duodenal mucosa, leading to subsequent regeneration of the mucosa. Several strategies are being pursued to overcome the alarming pandemics of obesity and type 2 diabetes (T2D). as part of a programme of care including. The procedure is performed under general anaesthesia, patients are discharged home the same day and it does not . It is provided. Significant improvements in fasting blood glucose, A1c, and weight can be obtained from duodenal mucosal resurfacing. Duodenal mucosal resurfacing Bergman et al, AASLD 2019 (Boston) Conclusions • The epidemiological burden of NASH is increasing • Lifestyle interventions are effective but only in a minority of patients • There are challenges to drug development for NASH • 1st phase 3 clinical trial results are encouraging • The future: combination . specialist follow-up appoint-ments for. The Duodenal Mucosal Resurfacing (DMR) procedure using the study device will be compared to a sham procedure. Early human clinical trial data suggest that endoscopic hydrothermal duodenal mucosal resurfacing is well tolerated in human subjects and has an acceptable safety profile. The duodenum, which is the first part of the small intestine immediately past the stomach, acts as a . Hydrothermal duodenal mucosal resurfacing (Revita DMR) is an investigational, catheter-based, upper endoscopic proceduredesigned to modify signaling from the duodenal sur- . She is working alongside Dr. Evans-Molina in the NIH sponsored The Rare and Atypical Diabetes Network (RADIANT) study . The startup will use the cash to continue backing clinical testing of its Revita Duodenal Mucosal Resurfacing System, which has already started an international multicenter trial and is slated to . It was selected for its national leadership in advanced interventional endoscopy, its record of robust clinical trial enrollment, and its key personnel . Once (and if) efficacy and safety can be proven, the research will move to larger numbers of people for phases 2 and 3. (duodenal mucosal resurfacing). . Exclusion of the duodenum through bariatric surgery has shown immediate benefit of improved glycemic control, independent of weight loss, in obese patients with type 2 diabetes mellitus (T2D). UCSD Diabetes Trial → Evaluation of the Efficacy and ... diabetes and dietary advice, as needed. The results were impressive: a year after the procedure, participants experienced both weight loss and a reduction in liver fat, and a majority had stopped using insulin entirely. A new procedure called DMR (duodenal mucosal resurfacing) is being studied in clinical trials to see if it can help people with type 2 diabetes improve their A1C without the need for insulin. The Liver Meeting 2019 - The Lancet Gastroenterology ... Endoscopic management of obesity | GI and Hepatology News The duodenum is connected to the lower part of your stomach and is the first part of your intestine to receive food from your stomach. These findings highlight the metabolic benefits that can be obtained in type 2 diabetes mellitus. Fractyl announced that 39 patients Type 2 diabetes patients treated using its investigative minimally invasive Revita Duodenal Mucosal Resurfacing System exhibited a reduction in blood sugar . It may offer a new treatment ap- Keywords Diabetes Research | Endocrinology | IU School of Medicine Can a New Procedure Help People with Type 2 Diabetes on ... Hydrothermal Duodenal Mucosal Resurfacing | Abdominal Key Resurfacing Duodenum Improves Glycemia in T2D | MedPage Today Fractyl gets FDA approval for Revita DMR IDE study to ... Insulin-Free Treatment For T2DM Patients -- Duodenal ... By Megan Brooks. consultations and post-procedure. She is also the site Co-Principal Investigator for REVITA-T2Di, which is an industry funded clinical trial evaluating the efficacy and safety of duodenal mucosal resurfacing in subjects with Type 2 diabetes on insulin therapy. Both conditions improve with duodenal exclusion surgery. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and . (AHEAD) trial,18,19 have shown the metabolic benefit of applying lifestyle modification in prediabetic patients and patients with frank diabetes in a controlled trial . Duodenal mucosal resurfacing It is hypothesized that this may reset the diseased duodenal enteroendocrine cells leading to restoration of the incretin effect. Following animal studies, which demonstrated feasibility and safety, the procedure has been applied in two human studies. Duodenal-Mucosal-Resurfacing-trial Clinical trials: Duodenal Mucosal Resurfacing (DMR) UCLH is to be one of the first centres in the world involved in an exciting new trial to treat poorly controlled type 2 diabetes with an endoscopic procedure called duodenal mucosal resurfacing or DMR. WALTHAM, Mass.--(BUSINESS WIRE)--Fractyl Laboratories Inc. (Fractyl) today announced that patient enrollment has begun in a multicenter clinical trial ("Revita-1" trial) being conducted in Europe and South America to evaluate the safety and performance of the Revita™ Duodenal Mucosal Resurfacing™ (DMR) System.Revita is the first non-invasive, implant free duodenal resurfacing . "Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis from the First-in-Human Proof-of-Concept Study" "This is the first peer-reviewed publication of human clinical data from the proof-of-concept trial," said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl. . The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-musical space, followed by an ablation of the duodenal mucosa. Fractyl Health's lead product candidate, Revita, is designed to remodel the duodenal lining via hydrothermal ablation (i.e., duodenal mucosal resurfacing) in order to edit abnormal intestinal . Duodenal Mucosal Resurfacing RCT •First sham-controlled, double-blind, prospective study •11 sites (9 in EU, 2 in Brazil) •Eligible patients (HbA1c of 7.5- Duodenal mucosal resurfacing is an investigational endoscopic procedure that thermally ablates duodenal mucosa, and it received the CE Mark in Europe in April, based on the results of this study . It involves a small tube, called a catheter, to be threaded through your digestive tract. In recent years, duodenal mucosal resurfacing (DMR) has shown its potential to improve glycemic indices. The Revita™ Duodenal Mucosal Resurfacing Procedure is a new investigational procedure for type 2 diabetes designed to evaluate your body's potential for better blood sugar control. The most recent study of duodenal mucosal resurfacing evaluated its effect on adults with Type 2 diabetes that were treated with insulin. 8 Data from human and animal model studies suggest that this is followed by an insulin-sensitizing effect that resembles the metabolic improvements observed after . Prior studies of duodenal mucosal resurfacing, conducted outside the United States, have shown promising results. Fractyl, the company that makes the duodenal mucosal resurfacing technology, is currently recruiting patients for the forthcoming trial. Insulin resistance is a core pathophysiological defect underscoring type 2 diabetes mellitus (T2DM) and non-alcoholic fatty liver disease (NAFLD). The trial, which is expected to enroll more than 300 patients at up to 35 sites in the U.S. and Europe, will support FDA clearance for the procedure, which is designed to . A new e ndoscopic duodenal mucosal resurfacing treatment could lead to T2D patients becoming insulin-free.. Endoscopic duodenal mucosal resurfacing (DMR), combined with glucagon-like peptide (GLP)-1 receptor agonist, has been shown to improve glycemic control in patients with T2DM, possibly enabling them to discontinue insulin therapy. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D). Duodenal mucosal resurfacing (DMR) has been associated with improvement in glycaemic parameters and liver function tests (LFTs) in type 2 diabetes. Endoscopic duodenal mucosal resurfacing is a single minimally invasive procedure that involves circumferential hydrothermal ablation of the duodenal mucosa, leading to subsequent regeneration of the mucosa. Randomized, Double-Blind, Sham-Controlled, Prospective, Multi-Center Pilot Study to Evaluate the Safety and Effectiveness of Duodenal Mucosal Resurfacing Using the Revita™ System in the Treatment of Type 2 Diabetes The company recently launched the pivotal REVITA-T2Di clinical trial to evaluate the treatment in this population, in hopes it will offer a new option for people with the . It involves the hydrothermal ablation of up to 14 cm of the duodenal mucosa through a specially designed endoscopic catheter [, , , ]. A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy. The researchers are currently conducting a study with a control arm as well as a trial to see if there is any synergistic effect when duodenal mucosal resurfacing is added to treatment with a . He's co-leading a clinical trial at Penn that is testing whether killing cells on the inner surface of the duodenum — the first part of the small intestine immediately past the stomach — can lead to better control of blood sugar in people with diabetes. Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy (REVITA-T2Di) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. mucosal resurfacing (DMR). Early human clinical trial data suggest that endoscopic hydrothermal duodenal mucosal resurfacing is well tolerated in human subjects and has an acceptable safety profile. It is intended as an outpatient therapy that can be performed in approximately one hour and allows . Known intestinal autoimmune disease, as evidenced by either a positive Anti-GAD . The Revita™ System is being investigated to assess the ability to improve glycemic control in conjunction with diet and exercise in patients with Type 2 diabetes who are inadequately controlled with oral anti-diabetic medications. 108 patients with suboptimally controlled type 2 diabetes were enrolled and randomly . Massachusetts-based Fractyl Laboratories has announced that it enrolled the first participant in its pivotal trial of Revita Duodenal Mucosal Resurfacing (DMR), an outpatient endoscopic procedure for type 2 diabetes patients. Objective Hydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. Background: The duodenum has become a metabolic treatment target through bariatric surgery learnings and the specific observation that bypassing, excluding or altering duodenal nutrient exposure elicits favourable metabolic changes. Duodenal mucosal resurfacing (DMR) is an endoscopic intervention developed to treat metabolic disease which has been shown to improve glycaemia in patients with poorly controlled T2DM. The REVITA-T2Di trial will evaluate the ability of a single Revita DMR treatment to allow patients currently on insulin therapy but with inadequate glycaemic control to achieve durable insulin-free glycaemic control. According to MDDI, Fractyl Labs said it will use the proceeds to support the Revita T2Di pivotal clinical trial of Revita DMR (duodenal mucosal resurfacing) for the treatment of patients with type 2 diabetes (T2D). He took part in an early duodenal mucosal resurfacing trial, in 2018, having lived with type 2 diabetes for 20 years. Duodenal mucosal resurfacing (DMR) is a novel, minimally invasive, catheter-based upper endoscopic procedure in-volving hydrothermal ablation of the duodenal mucosa and subsequent mu-cosal healing. NEW YORK (Reuters Health) - A single endoscopic duodenal mucosal resurfacing (DMR), coupled with a GLP-1 receptor agonist and lifestyle coaching, can eliminate the need for insulin in most type-2 diabetes patients and improve glucose regulation and overall metabolic health, according to results of a pilot study. A Prospective, Randomized, Double-Blind, Sham-Controlled, Multi-Center Pivotal Study to Evaluate the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy. Gregory Ginsberg, a Penn Medicine doctor, is exploring a new frontier in the treatment of type 2 diabetes. IU is the first of several study sites to be activated in the US. The goal of the current study was to assess the safety . - July 16, 2015 - Fractyl Laboratories Inc. (Fractyl) today announced that patient enrollment has begun in a multicenter clinical trial ("Revita-1" trial) being conducted in Europe and South America to evaluate the safety and performance of the Revita™ Duodenal Mucosal Resurfacing™ (DMR) System. Patients and methods This was a single-center, open-label pilot study. This is the first study in humans to show that DMR lowers blood sugars safely in 3 and 6 months. Hydrothermal Duodenal Mucosal Resurfacing: Role in the Treatment of Metabolic Disease.. Mount Sinai Beth Israel; Mount Sinai Brooklyn; The Mount Sinai Hospital; Mount Sinai Morningside; Mount Sinai Queens; Mount Sinai South Nassau; Mount Sinai West 'I was started on insulin in 2012, as my other medication wasn't . About Fractyl and the Revita™ Duodenal Mucosal Resurfacing (DMR) System Fractyl Laboratories Inc., a private company based in Waltham, MA, was founded with the mission to change the treatment of . It is minimally invasive and performed in an outpatient setting using a system that consists of a console and a novel single-use balloon catheter, the . This US Pilot Study is designed to determine whether the Revita™ DMR endoscopic procedure is safe and effective in the treatment of type 2 diabetes. Duodenal Mucosal Resurfacing (DMR) could be a new treatment for type 2 diabetes. Condition: Type 2 Diabetes; Intervention: Intervention Type: Device Intervention Name: Duodenal Mucosal Resurfacing (DMR) Description: The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. This article describes the rationale for this endoscopic approach and its early human use, including safety, tolerability, and early efficacy. Jump to this post. The sham procedure is similar to the DMR procedure, but leaves out the heating, which is the key therapeutic element of the DMR procedure. Known as duodenal mucosal resurfacing (DMR), the procedure cleanses the duodenal mucosa by taking out the extra layer that has developed due to consumption of foods high in fat and sugar. This article describes the rationale for this endoscopic approach and its early human use, including safety, tolerability, and early efficacy. A small multicenter study shows durable improvement in T2D indicators at 1 year after endoscopic duodenal mucosal resurfacing. This procedure has been shown to improve glycemic control in patients with T2D. This study aimed to assess the effect of DMR in patients with NASH. The purpose of this study is to demonstrate the safety and effectiveness of the Fractyl DMR Procedure using the Revita™ System compared to a sham procedure. Fractyl's Revita examines the effect of Fractyl's Revita DMR treatment on glycemic control and insulin requirements. Revita is the first . Duodenal Mucosal Resurfacing Open Label Trial, 12 months •9 countries, 37 pts Van Baar, et al. DMR improves glycemic control in patients with type 2 diabetes (T2D), most likely by altered duodenal signaling leading to insulin sensitization. Revita is . Fractyl Laboratories says the money will fund a pivotal clinical trial of its potential non-drug, non-surgical treatment for Type 2 diabetes. Duodenal Mucosal Resurfacing (DMR) is performed on a part of your small intestine, called the duodenum (do-odd-neh-um). Healing of the duodenal mucosa can be observed in as little as 1 month and was observed throughout the duration of the study period. Duodenal mucosal resurfacing (DMR) is an endoscopic procedure that applies hydrothermal energy to the duodenum, leading to ablation and subsequent regeneration of the duodenal mucosa. Condition: Type 2 Diabetes; Intervention: Intervention Type: Device Intervention Name: Duodenal Mucosal Resurfacing (DMR) Description: The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. There are plans to treat up to 430 type 2 patients aged 21 to 70 in trials conducted across 35 sites in the UK, Europe and the US. US-based biotechnology firm Fractyl Laboratories has received the US Food and Drug Administration (FDA) approval to start an Investigational Device Exemption (IDE) study of Revita DMR (duodenal mucosal resurfacing) treatment. OBJECTIVE To assess procedural safety and glycemic indices at 6 months in a first-in-human study of duodenal mucosal resurfacing (DMR), a novel, minimally invasive, upper endoscopic procedure involving hydrothermal ablation of the duodenal mucosa, in patients with type 2 diabetes and HbA1c ≥7.5% (58 mmol/mol) on one or more oral antidiabetic agents. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D). . Background: The duodenum is a key metabolic signaling center, and duodenal mucosal hyperplasia is a potential therapeut ic target for insulin-resistance (IR)- related metabolic diseases. Duodenal mucosal resurfacing (DMR) is a minimally inva-sive endoscopic procedure performing circumferential mucosal lift and hydrothermal ablation of the duodenal mucosa.15 The first- in- human safety trial showed that DMR is safe and able to improve glycaemic control in proportion to the length of the Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy. The duodenal mucosal resurfacing (DMR) intervention is a novel therapy for the treatment of T2DM. This procedure has been shown to improve glycemic control in patients with T2D. Keywords The purpose of this study is to demonstrate the efficacy and safety of the Fractyl duodenal mucosal resurfacing (DMR) Procedure using the Revita System compared to a sham procedure for the treatment of uncontrolled type 2 diabetes. Gut 2019. Based on new discoveries in metabolic science, the investigational Revita ™ duodenal mucosal resurfacing (DMR) procedure targets the upper intestine, or duodenum, with the aim of addressing a root cause of insulin resistance in type 2 diabetes. Print details; . The IDE trial, dubbed Revita T2Di, is a randomised, double-blind, sham-controlled study designed to enrol 300 type 2 . Duodenal mucosal resurfacing in diabetes Arun Sanyal (Virginia Commonwealth University, VA, USA) and colleagues presented the results of a randomised, sham-controlled trial of duodenal mucosal resurfacing (DMR) in patients with NASH and type 2 diabetes. Subjects randomized to the DMR procedure are followed per protocol for 48 Weeks. Image (C) Fractyl Laboratories, Inc. Lexington, MA Director of Penn Interventional and Advanced Endoscopy Gregory G. Ginsberg, MD, is collaborating with Anastassia Amaro, MD, Medical Director of Penn Metabolic Medicine, in a large, multicenter pilot trial to assess the efficacy and safety of a novel . LEXINGTON, Mass.--(BUSINESS WIRE)--Fractyl Laboratories Inc. today announced positive results from the Revita-2 trial evaluating Revita DMR (duodenal mucosal resurfacing) for the treatment of type . Endoscopic duodenal resurfacing ablates the duodenal mucosa to treat type II diabetes. Bariatric surgery and other manipulations of the upper intestine, in particular the duodenum, have shown that limiting nutrient . The FDA has granted breakthrough device designation to Fractyl Laboratories Inc. for Revita DMR, a duodenal mucosal resurfacing treatment for patients with type 2 diabetes. In a recent trial, a new, minimally invasive upper endoscopic procedure called duodenal mucosal resurfacing (DMR) showed promise in improving biomarkers of non-alcoholic steatohepatitis (NASH) and type 2 diabetes in people with the conditions. Fractyl Health, a biotech company focused on addressing the causes of type 2 diabetes, is testing a new therapy called Revita DMR . Duodenal mucosal resurfacing (DMR) is a novel endoscopic procedure that has been shown to improve glycaemic control in people with type 2 diabetes mellitus (T2D . Phase 1 research studies efficacy and safety in small numbers of people. The duodenum has become recognized as a metabolic signaling center that is involved in regulating insulin action and, therefore, insulin resistance states such as type 2 diabetes. Duodenal mucosal resurfacing (DMR) is an endoscopic intervention in which the duodenal mucosa is ablated by hydrothermal energy. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-musical space, followed by an ablation of the duodenal mucosa.

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