The duodenum is where absorption of nutrients begins and hormones that control blood sugar levels are produced. . It is usually carried out as a day case and involves the ablation of the duodenal mucosa. Early human clinical trial data suggest that endoscopic hydrothermal duodenal mucosal resurfacing is well tolerated in human subjects and has an acceptable safety profile. Published online 2019 Jul 22. . medwireNews: Duodenal mucosal resurfacing (DMR) combined with glucagon-like peptide (GLP)-1 receptor agonists could enable some people with type 2 diabetes to discontinue insulin therapy, suggest findings from the pilot INSPIRE study.. Presenting the research at UEG Week Virtual 2020, Suzanne Meiring (Amsterdam University Medical Center, the Netherlands) explained that DMR "causes . 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. Known as duodenal mucosal resurfacing (DMR), the procedure is a new investigational therapy for type 2 diabetes that targets the area of the small intestine called the duodenum. - 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. Conclusion: DMR didn't increase insulin sensitivity in insulin resistant women with PCOS and obesity in this trial. Participating in another ongoing clinical trial of an investigational drug or device. It is provided. Duodenal mucosal resurfacing (DMR) is an endoscopic procedure where the duodenal mucosa is ablated to treat type 2 diabetes. BackgroundEndoscopic bariatric and metabolic therapies (EBMTs) are procedures that utilize instruments that require flexible endoscopy or placement of devices for inducing weight loss. In total, 16 patients with T2D underwent DMR combined with a GLP-1RA. DMR is an upper endoscopic, catheter-based procedure that uses a combination of circumferential mucosal lift (via a homogeneous submucosal injection, separating su- perficial mucosa from underlying muscularis) of the target segment of duodenum and hydrothermal ablation via a novel, wire-guided balloon catheter system (Fig. 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 NCT02879383. 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) irrespective of body mass index (BMI) changes. The procedure is part of the REVITA T2Di clinical study, a randomized clinical trial in patients with inadequately controlled type 2 diabetes. or current upper gastro-intestinal bleeding conditions such as ulcers, gastric . 16 17 the … DMR leads to improved glycaemia and additional metabolic improvements, such as liver fat reduction, without the disadvantages of anatomy-changing surgery. 15The first- in- human safety trial showed that DMR is safe and able to improve glycaemic control in proportion to the length of the ablated duodenal mucosal Duodenal mucosal resurfacing (DMR) is a new endoscopic ablation technique aimed at improving glycemia and metabolic control in patients with type 2 diabetes mellitus (T2DM). Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy. Duodenal mucosal resurfacing (DMR) is a single, minimally invasive endoscopic procedure that involves circumferential hydrothermal ablation of the duodenal mucosa resulting in subsequent regeneration of the mucosa . This effect was more notable in those patients where resurfacing of the long segment of duodenum was done (mean A1c: 2.5 + 0.5%), whereas those patients who underwent resurfacing of the . Duodenal mucosal resurfacing (Fractyl, Lexington, Mass.) duodenal mucosal resurfacing (dmr) is a minimally invasive endoscopic procedure performing circumferential mucosal lift and hydrothermal ablation of the duodenal mucosa. This clinical trial is for men or women who have inadequately controlled Type 2 diabetes and are currently on stable doses of basal insulin. Duodenal mucosal resurfacing (DMR) is a minimally invasive endoscopic procedure involving catheter-based hydrothermal ablation of duodenal mucosa . Duodenal mucosal resurfacing (DMR) is a procedure used to treat the lining of the duodenum, the first part of the small intestine. (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices. A small multicenter study shows durable improvement in T2D indicators at 1 year after endoscopic duodenal mucosal resurfacing. . The purpose of this research study is to learn more about the use of the Fractyl Revita System for the treatment of Type 2 diabetes for patients who are on insulin therapy. Duodenal mucosal resurfacing was studied in type 2 diabetes patients as a minimally invasive procedure that could offer an alternative treatment for these patients and further studies are needed to determine the place of this procedure in the treatment of type 2 Diabetes. involves saline lifting of the duodenal mucosa circumferentially prior to thermal ablation using an inflated balloon filled with heated water. 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. 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 . Once the catheter is advanced into the duodenum, a balloon is inflated with heated water . The conceptual basis of the procedure is derived from observations that bariatric bypass procedures eliminating the duodenal mucosa as an absorptive surface for food, such as the Roux-en-Y gastric bypass, produce weight loss and improvements in glycemia that cannot be explained by a malabsorptive process (2,3).Further rationale is that placement of an endoluminal sleeve preventing physical . This study aimed to evaluate in a critical and systematic way the metabolic effects of this procedure. The catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal . . Researchers are testing a new method, Duodenal mucosal resurfacing (DMR), which is a novel, minimally invasive, upper endoscopic procedure involving heating of the duodenal . Duodenal mucosal resurfacing (DMR) is a recent novel endoscopic procedure involving the elective ablation of duodenal mucosa with hydrothermal energy followed by subsequent regeneration, with the aim of treating metabolic disorders 10 . July 16, 2015 By Fink Densford. It is intended as an outpatient therapy that can be performed in approximately one hour and allows . Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy . A prospective trial of 42 subjects reported that the device was successfully implanted in 39 patients and they were followed up for 1 year. The prespecified safety analysis Duodenal mucosal resurfacing (DMR) is a minimally inva- tabulated the difference in the proportion of patients who expe- sive endoscopic procedure performing circumferential mucosal rienced ≥1 major complication (DMR vs sham). 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. Bile acids function as intestinal signaling molecules in glucose and energy metabolism via the . @ltssjs, Duodenal Mucosal Resurfacing (DMR) research in people with type 2 diabetes is still in the early stages. These results, from a mixed meal tolerance test, have . Both conditions improve with duodenal exclusion surgery. 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) is a minimally invasive endoscopic procedure performing circumferential mucosal lift and hydrothermal ablation of the duodenal mucosa. Read our disclaimer for details. This promotes healthy regrowth of the lining of the duodenum within 12 weeks with the goal of reducing insulin resistance and excess insulin in the blood. These improvements were maintained for the duration of the study. Duodenal Mucosal Resurfacing (DMR) could be a new treatment for type 2 diabetes. 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. Insulin resistance is a core pathophysiological defect underscoring type 2 diabetes mellitus (T2DM) and non-alcoholic fatty liver disease (NAFLD). DMR is not being ignored. Resurfacing through hydrothermal ablation allows a restoration of a normal mucosal interface that corrects this abnormal signal. 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. mucosal resurfacing (DMR). Known active coagulopathy, or current upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, or congenital or acquired intestinal telangiectasia 26. Duodenal mucosal resurfacing (DMR) is safe and provides beneficial disease-modifying metabolic effects in patients with type 2 diabetes (T2D) with or without nonalcoholic fatty liver disease (NAFLD), according to a study in Gut.. Summary Eligibility . WALTHAM, Mass. DMR involves catheter-based circumferential mucosal lifting followed by hydrothermal ablation of duodenal mucosa. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation 47. The Revita DMR procedure appeared to be safe and well tolerated in this first-in-human trial. Duodenal mucosal resurfacing (DMR) is an innovative endoscopic bariatric and metabolic therapy (EBMT) emerging in recent years. The study will evaluate whether a one-time procedure called Revita® duodenal mucosal resurfacing (DMR) can help patients improve their blood sugar control and reduce or eliminate their need to take insulin. Endoluminal Bariatric Therapies, such as endoluminal sleeves or barriers, duodenal mucosal resurfacing technology, and magnetic anastomoses may emerge to fill . Phase 1 research studies efficacy and safety in small numbers of people. History of non-adherence to treatment in the . Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita® System in Subjects With Type 2 Diabetes on Insulin Therapy a study on Diabetes Diabetes Type 2 for people ages 21-70 ( full criteria) at Coronado, California and other locations study started March 2021 estimated completion January 2025 by Georges Argoud This article describes the rationale for this endoscopic approach and its early human use, including safety, tolerability, and early efficacy. This study aimed to assess the effect of DMR in patients with NASH. 2020 Feb; 69(2): 295-303. 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. 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. Duodenal mucosal resurfacing (DMR) is an innovative endoscopic bariatric and metabolic therapy (EBMT) emerging in recent years. Endoscopic Duodenal Mucosal Resurfacing for the Treatment of Type 2 Diabetes: 6-Month Interim Analysis From the First-in-Human Proof-of-Concept Study. Once (and if) efficacy and safety can be proven, the research will move to larger numbers of people for phases 2 and 3. Print details; . Hydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. . Trial registration number NCT02413567. There remains, however, a large demand for less invasive and potentially cheaper or even reversible procedures that impart a similar effect on obesity and its related comorbidities. The Duodenal Mucosal Resurfacing (DMR) procedure using the study device will be compared to a sham procedure. It uses the duodenum to achieve better glycemic and weight control. It uses the duodenum to achieve better glycemic and weight control. The duodenal-jejunal bypass liner (DJBL) is a common form of treatment for obesity, T2D, and nonalcoholic fatty liver disease. duodenal mucosal resurfacing (dmr) is a minimally inva- sive endoscopic procedure performing circumferential mucosal lift and hydrothermal ablation of the duodenal mucosa.15the first- in- human safety trial showed that dmr is safe and able to improve glycaemic control in proportion to the length of the ablated duodenal mucosal segment.16 17the … Gut. The procedure consists of an implant anchored in the proximal duodenum and a sleeve extended into the jejunum, forming a bypass/biliopancreatic . Early human clinical trial data suggest that endoscopic hydrothermal duodenal mucosal resurfacing is well tolerated in human subjects and has an acceptable safety profile. At . . Unwilling or unable to perform SMBG, complete the patient diary, or comply with study Patients with definite, biopsy-proven NASH (nonalcoholic . 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 was a 1.2% + reduction in A1c for the full cohort at the end of the study (P<0.001). consultations and post-procedure. 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). The procedure is designed to rejuvenate the lining of the duodenum. The double-blind, multicenter, randomized controlled trial assessed the efficacy and safety of DMR in patients with T2D with or without NAFLD compared with a sham . 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. 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 . He took part in an early duodenal mucosal resurfacing trial, in 2018, having lived with type 2 diabetes for 20 years. 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. The trial is a prospective, randomized, double-blind, sham . Researchers at the Amsterdam University Medical Center in the Netherlands have now tested a novel minimally-invasive endoscopic ablation procedure called duodenal mucosal resurfacing (DMR) on 16 type 2 diabetes patients who were dependent on insulin. Duodenal mucosal resurfacing (DMR) has been associated with improvement in glycaemic parameters and liver function tests (LFTs) in type 2 diabetes. Duodenal mucosal resurfacing. DMR may offer a new minimally invasive treatment approach for insulin-resistant metabolic diseases, including T2DM, nonalcoholic fatty liver disease (NAFLD), and nonalcoholic steatohepatitis (NASH . As a part of the digestive system, the gut is one of the largest and . specialist follow-up appoint-ments for. The duodenal mucosal resurfacing intervention (Revita DMR, Fractyl Laboratories) is an outpatient endoscopic therapy that uses heat to resurface the lining of the upper intestine. Duodenal mucosal resurfacing (DMR) is a novel, minimally invasive, . a study on Diabetes Diabetes Type 2. as part of a programme of care including. lift and hydrothermal ablation of the duodenal mucosa.15 The Secondary endpoints . This procedure has been shown to improve glycemic control in patients with T2D. It is hypothesized that this may reset the diseased duodenal enteroendocrine cells leading to restoration of the . This article describes the rationale for this endoscopic approach and its early human use, including safety, tolerability, and early efficacy. Duodenal mucosal resurfacing (DMR) is a new endoscopic ablation technique aimed at improving glycemia and metabolic control in patients with type 2 diabetes mellitus (T2DM). This article describes the rationale for this endoscopic approach and its early human use, including safety, tolerability, and early efficacy. 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. This is the first study in humans to show that DMR lowers blood sugars safely in 3 and 6 months. Revita DMR (duodenal mucosal resurfacing) is a first-in-class intervention targeting the role of the intestine in metabolic disease. Duodenal mucosal resurfacing (DMR) is a novel, minimally invasive, catheter-based upper endoscopic procedure involving hydrothermal ablation of the duodenal mucosa and subsequent mucosal healing. Fractyl Laboratories has announced the enrolment of the first patient in a pivotal clinical trial of Revita DMR (duodenal mucosal resurfacing) for patients with type 2 diabetes. DMR appears to improve insulin resistance, which is the root cause of T2DM, but its mechanism of action is largely unknown. The procedure consists of duodenal sizing, saline . Electronic searches were performed evaluating the DMR procedure based on predefined inclusion and . Evaluation of Duodenal Mucosal Resurfacing in Subjects With Type 2 Diabetes The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. . This study aimed to evaluate in a critical and systematic way the metabolic effects of this procedure. A new endoscopic duodenal mucosal resurfacing treatment could lead to T2D patients becoming insulin-free. The sham procedure is similar to the DMR procedure, but leaves out the heating, which is . Background and Aims Duodenal mucosal resurfacing (DMR) is an endoscopic intervention in which the duodenal mucosa is ablated by hydrothermal energy. 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. 45. Gut. Revita, a treatment that involves duodenal. Duodenal mucosal resurfacing (DMR) is a procedure that consists of hydrothermal ablation of the duodenal mucosa. The goal of the current study was to assess the safety . A1c reduction of 1 . Fractyl Labs said today it enrolled the 1st patients in a trial of its Revita duodenal mucosal resurfacing system designed to treat the digestive causes of insulin . Learn more about this technology and its performance in current clinical trials. Free full text . Subjects with active helicobacter pylori infection (Subjects may be enrolled if they had history of h pylori infection and were successfully treated) 27. ClinicalTrials.gov Identifier: NCT02413567 Fractyl Laboratories, Inc., a Waltham-based biotechnology company developing novel treatments for type 2 diabetes, recently announced data of a proof-of-concept, single-site trial in 39 patients, which determined that a minimally invasive surgical procedure using the company's Revita™ Duodenal Mucosal Resurfacing™ (DMR) System provided beneficial changes in blood sugar in patients with . In the safety population (N = 46), between 6 and 24 months post-DMR, two patients . In one trial, lira glutide reduced liver . 2). Duodenal mucosal resurfacing (DMR) is safe and provides beneficial disease-modifying metabolic effects in patients with type 2 diabetes (T2D) with or without nonalcoholic fatty liver disease (NAFLD), according to a study in Gut. It involves a small tube, called a catheter, to be threaded through your digestive tract. Patients with poorly controlled type 2 diabetes who underwent a novel, minimally invasive, endoscopic procedure called Revita® duodenal mucosal resurfacing (DMR) had significantly improved blood glucose (sugar) levels, liver insulin sensitivity, and other metabolic measures three months later, according to new data from the REVITA-2 study. . . Duodenal mucosal resurfacing versus duodenal-jejunal bypass liner. The technique, known as duodenal mucosal resurfacing, involves the balloon being threaded on a long, thin tube down the throat, into the stomach, and then the duodenum, the first part of the small intestine. Introduction: Duodenal mucosal resurfacing (DMR) is a novel therapy for T2DM. support, helping peo-ple to adjust to a. healthier lifestyle post-procedure, with. 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 . 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. . Early human clinical trial data suggest that endoscopic hydrothermal duodenal mucosal resurfacing is well tolerated in human subjects and has an acceptable safety profile. Abstract: Objective Hydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. It is an innovative treatment which removes the need for incisions, stitches or implants. 25. 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. 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) targets this specific biology with the assumption that the duodenal surface is in some way mediating an abnormal signal that emanates to endogenous insulin-sensitive tissues.
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