lift and hydrothermal ablation of the duodenal mucosa.15 The Secondary endpoints . Duodenal mucosal resurfacing (DMR) is a procedure used to treat the lining of the duodenum, the first part of the small intestine. . a study on Diabetes Diabetes Type 2. Patients and methods This was a single-center, open-label pilot study. 25. specialist follow-up appoint-ments for. This study aimed to assess the effect of DMR in patients with NASH. The procedure is part of the REVITA T2Di clinical study, a randomized clinical trial in patients with inadequately controlled type 2 diabetes. The procedure is designed to rejuvenate the lining of the duodenum. Hydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. The goal of the current study was to assess the safety . The Revita DMR procedure appeared to be safe and well tolerated in this first-in-human trial. Duodenal Mucosal Resurfacing (DMR) is performed on a part of your small intestine, called the duodenum (do-odd-neh-um). This procedure has been shown to improve glycemic control in patients with T2D. or current upper gastro-intestinal bleeding conditions such as ulcers, gastric . Revita is the first . 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.. Duodenal mucosal resurfacing (DMR) has been associated with improvement in glycaemic parameters and liver function tests (LFTs) in type 2 diabetes. DMR is not being ignored. 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. It uses the duodenum to achieve better glycemic and weight control. Revita, a treatment that involves duodenal. In total, 16 patients with T2D underwent DMR combined with a GLP-1RA. Duodenal mucosal resurfacing (DMR) is a minimally invasive endoscopic procedure involving catheter-based hydrothermal ablation of 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 This study aimed to evaluate in a critical and systematic way the metabolic effects of this procedure. Background and Aims Duodenal mucosal resurfacing (DMR) is an endoscopic intervention in which the duodenal mucosa is ablated by hydrothermal energy. NCT02879383. 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. In one trial, lira glutide reduced liver . involves saline lifting of the duodenal mucosa circumferentially prior to thermal ablation using an inflated balloon filled with heated water. Participating in another ongoing clinical trial of an investigational drug or device. 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 . 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. . Duodenal mucosal resurfacing (DMR) is an innovative endoscopic bariatric and metabolic therapy (EBMT) emerging in recent years. . 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. 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. Learn more about this technology and its performance in current clinical trials. 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. Based on these considerations, a novel minimally invasive endoscopic approach, duodenal mucosal resurfacing, was designed whose purpose is to ablate the duodenal mucosa in order to induce its regeneration. Subjects with active helicobacter pylori infection (Subjects may be enrolled if they had history of h pylori infection and were successfully treated) 27. 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 . At . @ltssjs, Duodenal Mucosal Resurfacing (DMR) research in people with type 2 diabetes is still in the early stages. There was a 1.2% + reduction in A1c for the full cohort at the end of the study (P<0.001). Unwilling or unable to perform SMBG, complete the patient diary, or comply with study These results, from a mixed meal tolerance test, have . WALTHAM, Mass. July 16, 2015 By Fink Densford. 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 . These improvements were maintained for the duration of the study. Gut. 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). 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). Early human clinical trial data suggest that endoscopic hydrothermal duodenal mucosal resurfacing is well tolerated in human subjects and has an acceptable safety profile. as part of a programme of care including. 2020 Feb; 69(2): 295-303. Bile acids function as intestinal signaling molecules in glucose and energy metabolism via the . 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. DMR appears to improve insulin resistance, which is the root cause of T2DM, but its mechanism of action is largely unknown. 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. . We perform a systematic review and meta-analysis to evaluate four modalities - intragastric balloon (IGB), endoscopic sleeve gastroplasty (ESG), duodeno-jejunal bypass liner (DJBL), and duodenal mucosa . 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. Researchers are testing a new method, Duodenal mucosal resurfacing (DMR), which is a novel, minimally invasive, upper endoscopic procedure involving heating of the duodenal . Fractyl Health has developed a new technology called duodenal mucosal resurfacing, which can "reset" your gut, leading to improvements in glucose levels and weight and a reduction in medications. 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 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 . . Endoluminal Bariatric Therapies, such as endoluminal sleeves or barriers, duodenal mucosal resurfacing technology, and magnetic anastomoses may emerge to fill . Print details; . 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. 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. 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 . Future . He took part in an early duodenal mucosal resurfacing trial, in 2018, having lived with type 2 diabetes for 20 years. The duodenum is where absorption of nutrients begins and hormones that control blood sugar levels are produced. 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 . Bariatric surgery has revolutionized obesity treatment. This clinical trial is for men or women who have inadequately controlled Type 2 diabetes and are currently on stable doses of basal insulin. 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. . 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. 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. 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 . 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 Revita DMR (duodenal mucosal resurfacing) is a first-in-class intervention targeting the role of the intestine in metabolic disease. Published online 2019 Jul 22. . Electronic searches were performed evaluating the DMR procedure based on predefined inclusion and . Duodenal mucosal resurfacing (DMR) is an innovative endoscopic bariatric and metabolic therapy (EBMT) emerging in recent years. mucosal resurfacing (DMR). Listing a study does not mean it has been evaluated by the U.S. Federal Government. History of non-adherence to treatment in the . This is the first study in humans to show that DMR lowers blood sugars safely in 3 and 6 months. DMR leads to improved glycaemia and additional metabolic improvements, such as liver fat reduction, without the disadvantages of anatomy-changing surgery. Thus, selecting the duodenal mucosa as a therapeutic target may only be effective in T2DM but not in euglycaemic insulin resistant states. DMR appears to improve insulin resistance, which is the root cause of T2DM, but its mechanism of action is largely unknown. Duodenal mucosal resurfacing (DMR) is a procedure that consists of hydrothermal ablation of the duodenal mucosa. The long-term safety findings from the REVITA-1 trial indicate that the DMR procedure was safe and well-tolerated. 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. It uses the duodenum to achieve better glycemic and weight control. duodenal mucosal resurfacing (dmr) is a minimally invasive 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 ablated duodenal mucosal segment. 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. Free full text . The procedure consists of duodenal sizing, saline . 16 17 the Once the catheter is advanced into the duodenum, a balloon is inflated with heated water . 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 . Anatomic abnormalities in the duodenum that would preclude the completion of the DMR procedure, including tortuous anatomy Malignancy newly diagnosed by endoscopy Upper gastrointestinal conditions such as ulcers, polyps, varices, strictures, congenital or acquired intestinal telangiectasia Contacts and Locations Go to As a part of the digestive system, the gut is one of the largest and . Early human clinical trial data suggest that endoscopic hydrothermal duodenal mucosal resurfacing is well tolerated in human subjects and has an acceptable safety profile. 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 . 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 . This article describes the rationale for this endoscopic approach and its early human use, including safety, tolerability, and early efficacy. The sham procedure is similar to the DMR procedure, but leaves out the heating, which is . 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. Read our disclaimer for details. Duodenal mucosal resurfacing. In this single-arm, prospective, open-label study, the authors examined the feasibility of combining lifestyle modifications, duodenal mucosal resurfacing (DMR), and a GLP-1RA in eliminating the need for insulin in patients with type 2 diabetes (T2D). 45. 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 duodenal mucosal resurfacing intervention (Revita DMR, Fractyl Laboratories) is an outpatient endoscopic therapy that uses heat to resurface the lining of the upper intestine. . This article describes the rationale for this endoscopic approach and its early human use, including safety, tolerability, and early efficacy. Once (and if) efficacy and safety can be proven, the research will move to larger numbers of people for phases 2 and 3. A new endoscopic duodenal mucosal resurfacing treatment could lead to T2D patients becoming insulin-free. Known active coagulopathy, or current upper gastro-intestinal bleeding conditions such as ulcers, gastric varices, strictures, or congenital or acquired intestinal telangiectasia 26. Insulin resistance is a core pathophysiological defect underscoring type 2 diabetes mellitus (T2DM) and non-alcoholic fatty liver disease (NAFLD). 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. 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. 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. 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 . 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. Duodenal Mucosal Resurfacing (DMR) could be a new treatment for type 2 diabetes. . duodenal mucosal resurfacing (DMR) procedure Courtesy of Fractyl Previous research has indicated that DMR is well tolerated and associated with only a few side effects, which dissipate over time. Duodenal mucosal resurfacing versus duodenal-jejunal bypass liner. Patients with definite, biopsy-proven NASH (nonalcoholic . ClinicalTrials.gov Identifier: NCT02413567 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. It is intended as an outpatient therapy that can be performed in approximately one hour and allows . 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. It is hypothesized that this may reset the diseased duodenal enteroendocrine cells leading to restoration of the . (clinical trial) studies new tests, treatments, drugs, surgical procedures or devices. 2). - 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. It is an innovative treatment which removes the need for incisions, stitches or implants. diabetes and dietary advice, as needed. 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. A small multicenter study shows durable improvement in T2D indicators at 1 year after endoscopic duodenal mucosal resurfacing. Summary Eligibility . 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. Resurfacing through hydrothermal ablation allows a restoration of a normal mucosal interface that corrects this abnormal signal. 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. Duodenal mucosal resurfacing (DMR) is an endoscopic procedure where the duodenal mucosa is ablated to treat type 2 diabetes. 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). The Duodenal Mucosal Resurfacing (DMR) procedure using the study device will be compared to a sham procedure. In the safety population (N = 46), between 6 and 24 months post-DMR, two patients . This study aimed to evaluate in a critical and systematic way the metabolic effects of this procedure. 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 BackgroundEndoscopic bariatric and metabolic therapies (EBMTs) are procedures that utilize instruments that require flexible endoscopy or placement of devices for inducing weight loss. 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. It involves a small tube, called a catheter, to be threaded through your digestive tract. Any other mental or physical condition which, in the opinion of the Investigator, makes the subject a poor candidate for clinical trial participation 47. Duodenal mucosal resurfacing (Fractyl, Lexington, Mass.) . 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. support, helping peo-ple to adjust to a. healthier lifestyle post-procedure, with. 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 46. A1c reduction of 1 . The trial is a prospective, randomized, double-blind, sham . 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. Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita System in Subjects With Type 2 Diabetes on Insulin Therapy . 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). DMR involves catheter-based circumferential mucosal lifting followed by hydrothermal ablation of duodenal mucosa. Both conditions improve with duodenal exclusion surgery. Electronic searches were performed evaluating the DMR procedure based on predefined inclusion and . 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. 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. It is provided. Evaluation of the Efficacy and Safety of Duodenal Mucosal Resurfacing Using the Revita System in Subjects With Type 2 Diabetes on Insulin Therapy.
