[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"marginal-ulcer-peptic-or-erosion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:marginal-ulcer-peptic-or-erosion":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":39,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100557838","marginal-ulcer-healing-with-low-thermal-argon-plasma-endoscopic-treatment-100557838",false,"NCT06543316","Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment","Accelerated Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment","AMULET","Inclusion Criteria:\n\n* Subjects aged 18 years and above, inclusive of both males and females.\n* Patients with a history of Roux-en-Y gastric bypass (RYGB) presenting symptoms indicative of marginal ulcers (MUs) such as abdominal pain, nausea, vomiting, gastrointestinal bleeding, or dysphagia.\n* Subjects must be scheduled for an EGD for the evaluation of these symptoms.\n* Marginal ulcers confirmed during the initial EGD.\n* Willingness to adhere to the SOC treatment, which includes PPIs.\n* Subjects able to tolerate repeated endoscopic procedures.\n* Capacity for providing informed consent and understanding of study requirements.\n* Willingness and ability to attend required follow-up assessments at 4 weeks (+\u002F- 1 week) and 8 weeks (+\u002F- 2 weeks).\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Unwillingness to undergo repeated endoscopies.\n* Inability or unwillingness to comply with the SOC.\n* Current use of systemic antibiotics.\n* Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.\n* Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.\n* Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.",[27,28,29,30,31,32,33,34,35,36,37,38],"Roux-en-y Anastomosis Site","Marginal Ulcer","Marginal Ulcer (Peptic) or Erosion","Ulcer","Ulcer, Gastric","Ulcer Gastrointestinal","Abdominal Pain","Nausea","Vomiting","GastroIntestinal Bleeding","Dysphagia","Ulcer Gastrojejunal",[40,41,42,43,44,45,46],"Argon Plasma Coagulation","APC","Low-Thermal Argon Plasma Endoscopic Treatment","Endoscopy","RYGB","Roux-en-Y Gastric Bypass","Ulcer Healing","RECRUITING","2026-06-23",{"date":50,"type":51},"2026-06-25","ACTUAL",{"date":53,"type":51},"2025-03-04",{"date":55,"type":21},"2028-06",{"name":57,"class":58},"Christopher C. Thompson, MD, MSc","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":22,"phases":71,"briefSummary":72,"conditions":73,"keywords":77,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":59},"100631003","the-transit-bipartition-with-the-use-of-a-metallic-anastomosis-clip-and-circular-fundocorporeal-gastroplication-100631003","NCT07495020","The Transit Bipartition With the Use of a Metallic Anastomosis Clip and Circular Fundocorporeal Gastroplication","The Laparoscopic Transit Bipartition Without Gastrectomy With Use of Metallic Anastomosis Clip (MAC) and Circular Fundocorporeal Gastroplication for Treating Type 2 Diabetes Mellitus and Obesity","MACBIPARTFCG","Inclusion Criteria:\n\n* Clinical diagnosis of Type 2 Diabetes Mellitus\n* BMI 25-35 kg\u002Fm2\n\nExclusion Criteria:\n\n* Insulin dependent diabetes\n* BMI \\\u003C25 and \\>35 kg\u002Fm2\n* History of surgery on the stomach\n* Less than 18 or more than 65 years of age\n* Psychiatric illness\n* Patients unwilling or unable to provide informed consent","65 Years",{"count":70,"type":21},90,[24],"This study evaluates a new surgical device - the Metallic Anastomotic Clip (MAC) - for performing a laparoscopic bypass gastroenteroanastomosis with entero-enteric anastomosis (transit bipartition \u002F \"dual-path\" procedure) in patients with type 2 diabetes mellitus (T2DM) who have overweight or Class I obesity (BMI 25-34.9 kg\u002Fm²).\n\nCurrently, most bariatric and metabolic surgery procedures are only approved for patients with a BMI above 35 kg\u002Fm². However, many T2DM patients have BMI less 34.9 kg\u002Fm2 and cannot access surgical treatment under existing national guidelines. The transit bipartition procedure addresses this gap by creating a second food pathway from the stomach to the ileum while preserving normal duodenal digestion - producing a strong incretin (GLP-1) effect similar to GLP-1 receptor agonists (e.g., semaglutide), without causing excessive weight loss or requiring lifelong vitamin supplementation.\n\nThe MAC is a novel compression anastomotic device designed to replace conventional hand-sewn or stapled anastomoses, potentially reducing complications such as anastomotic leak, bleeding, marginal ulcers, and strictures, while also lowering operative costs.\n\nParticipants will be randomised into three groups. The study will assess metabolic outcomes (T2DM remission, glycaemic control), surgical safety, quality of life, and cost-effectiveness over a follow-up period of 2026-2027.",[74,75,29,76],"Type 2 Diabetes Mellitus (T2DM)","Obesity & Overweight","Leakage, Anastomotic",[78,79,80,81],"Metallic Anastomotic Clip","Metabolic bariatric surgery","obesity","Type 2 diabetes mellitus","2026-05-02",{"date":84,"type":51},"2026-05-07",{"date":86,"type":51},"2026-04-30",{"date":88,"type":21},"2028-05-30",{"name":90,"class":58},"The Society of Bariatric and Metabolic Surgeons of Kazakhstan"]