[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Christopher C. Thompson, MD, MSc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":182},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,60,91,118,148],{"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":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":67,"targetDuration":4,"studyType":22,"phases":69,"briefSummary":70,"conditions":71,"keywords":78,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":59},"100558632","necrosectomy-with-cryotechnology-for-accelerated-removal-100558632","NCT06553651","Necrosectomy With Cryotechnology for Accelerated Removal","NECTAR","Inclusion Criteria:\n\n* Subjects aged 18 years and above, inclusive of both males and females.\n* Patients with symptomatic pancreatic necrosis resulting from acute pancreatitis, indicated for endoscopic necrosectomy following endoscopic ultrasound (EUS)-guided drainage.\n* Imaging indicative of ≥30% necrotic material within the pancreas.\n* Walled-off pancreatic necrosis (WOPN) size ≥6 cm.\n* Subjects able to tolerate repeated endoscopic procedures.\n* Capacity for providing informed consent.\n* Understanding of study requirements, provision of written informed consent, and willingness and ability to attend required follow-up assessments through 21 (+\u002F- 7) days.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Unwillingness to undergo repeated endoscopies.\n* Presence of documented Pseudoaneurysm \\> 1cm within the WOPN.\n* Intervening gastric varices or unavoidable blood vessels within the access tract.\n* Use of dual antiplatelet therapy or therapeutic anticoagulation that cannot be temporarily discontinued.\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.",{"count":68,"type":21},20,[24],"Pancreatic necrosis is a serious complication of acute pancreatitis. Pancreatic necrosis involves the irreversible death of pancreatic tissue, which can lead to severe health issues, including infections and an increased risk of death. An endoscopic procedure called direct endoscopic necrosectomy (DEN) is typically performed to remove this necrotic pancreatic tissue as a minimally invasive treatment. This procedure is performed using a thin, flexible, lighted tube called an endoscope and endoscopic instruments that are used with working channels through the scope. Current methods for removing necrotic tissue involve using endoscopic devices such as snares, baskets, nets, and forceps. However, these standard methods are often not very effective because the necrotic tissue can be sticky and hard to grasp. This DEN procedure is part of regular clinical care to treat this condition and remove necrotic tissue from the pancreas.\n\nFor this research study, the same DEN procedure will be followed with the exception of the device used for the removal of the necrotic tissue. Instead of using forceps, snares, or other traditional tools, a cryoprobe will be used. Cryoprobes work by using extremely cold temperatures to freeze and adhere to the necrotic tissue, making it easier to remove. This method might be better because it can secure larger tissue samples and potentially reduce complications associated with traditional methods. Cryotechnology is successfully used in endoscopy to remove necrotic tissue, foreign bodies and more, but has not been extensively tested in pancreatic necrosis. Cryoprobes are FDA approved medical devices with an established safety record. They are used successfully in very sensitive areas such as the lungs. This study aims to evaluate the safety and effectiveness of cryotechnology for DEN.",[72,73,74,75,76,77],"Pancreatic Necrosis","Acute Pancreatitis","Acute Pancreatic Necrosis","Necrosis","Necrosis Pancreas","Walled-Off Pancreatic Necrosis",[79,80,81,82,83,84],"Direct Endoscopic Necrosectomy (DEN)","Endoscopic Necrosectomy","Pancreatic Necrosectomy","Necrosectomy","Cryotherapy","Cryotechnology",{"date":50,"type":51},{"date":87,"type":21},"2026-12",{"date":89,"type":21},"2029-06",{"name":57,"class":58},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":101,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":113,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":117,"locationsCount":59},"100531527","trans-nasal-endoscopy-for-bariatric-patients-100531527","NCT06200961","Trans-nasal Endoscopy for Bariatric Patients","Use of Sedation-Free Transnasal Endoscopy to Improve Access and Lower Costs of Endoscopic Evaluations in a Bariatric Medical and Surgical Program","TNE","Inclusion Criteria:\n\n1. Patient 18 years of age and less than 90 years of age with clinically referred for esophagoscopy, gastroscopy, or esophagogastroduodenoscopy (EGD)\n2. Cared for in metabolic and bariatric clinic\n\nExclusion Criteria:\n\n1. Patient \\\u003C18 years of age\n2. Medically contraindicated to perform EGD or TNE\n3. Inability to provide informed consent","90 Years",{"count":20,"type":21},[24],"This study plans to learn if the EvoEndo Endoscopy system can be used to evaluate, provide and follow up care for upper gastrointestinal tract diseases in the bariatric population. The smallest current scope available for such a technique is an adult transnasal endoscope with a larger diameter, a pulmonary bronchoscope or Ear Nose and Throat (ENT) laryngoscope. This study is evaluating a newly Food and Drug Administration (FDA) cleared ultra-slim, single-use, endoscope specifically designed for transnasal endoscopy to evaluate its use in adult upper tract gastrointestinal diseases. If such a technique is successful it could improve the safety, cost, and access of endoscopic care for patients in need of an endoscopic evaluation for a bariatric medical condition.",[104,105,106,107,108],"Obesity","Obesity, Morbid","Obese","GI Disorders","Gastrointestinal Diseases",[110,111,112,43],"Transnasal Endoscopy (TNE)","Esophagogastroduodenoscopy (EGD)","Upper Endoscopy",{"date":50,"type":51},{"date":115,"type":51},"2026-04-20",{"date":55,"type":21},{"name":57,"class":58},{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":135,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":59},"100556749","h-pylori-eradication-with-argon-plasma-during-endoscopy-100556749","NCT06529159","H. Pylori Eradication With Argon Plasma During Endoscopy","H. Pylori Eradication With Argon Plasma During Endoscopy (HEAPE)","HEAPE","Inclusion Criteria:\n\n1. Subjects must be 18 years or older\n2. Confirmed untreated H. pylori infection\n3. Able to understand and sign informed consent\n4. Available to return for all routine follow-up study visits\n5. Patients should have upper endoscopy scheduled according to latest guidelines, e.g., as a part of their diagnostic work-up of HP positive test, regardless of their decision to participate in the study.\n\nExclusion Criteria:\n\n1. Patients actively undergoing H.pylori eradication therapy treatment with antibiotics or proton pump inhibitors (PPIs) two weeks prior to the HEAPE procedure.\n2. Pregnancy or puerperium\n3. Severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)\n4. Lactation\n5. An inability to provide informed consent\n6. Any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study.\n7. Hernias \u002F aspiration risk",{"count":68,"type":21},[24],"The objective of the study is to investigate the efficacy and safety of an argon plasma-based therapy - HEAPE - in treating H. pylori infections during endoscopic procedures. By filling the stomach with sodium chloride solution that is treated with APC (PAL), the Investigators hypothesize a significant reduction in H. pylori. The use of PAL instead of direct application of APC allows for a broader and more homogeneous application throughout the stomach and a faster procedure time, as the fluid bypasses the thermal effects typically associated with higher electrical power settings and focuses on the bactericidal action of PAL. It is a procedure that does not involve thermal ablation of the stomach lining. Thus, side effects should be expected to be as low as possible.\n\nTwo different PAL generation modalities will be compared in this study:\n\n1. HEAPE direct: This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach.\n2. Pre-HEAPE: This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope.\n\nTo evaluate the immediate effect of this novel treatment approach the metabolic activity of H. pylori will be assessed using a urea breath test (UBT) before and after treatment. A reduction in H. pylori levels can be detected by a reduction in urease activity in the breath test.\n\nAfter the HEAPE procedure, patients are treated with antibiotics (best practice) as they would be under normal circumstances. Four weeks after treatment, another UBT is performed to determine if H. pylori has been eradicated or if additional antibiotic treatment is indicated.\n\nThis two-arm, randomized, pilot, single-center, prospective clinical study is designed to evaluate the safety, tolerability and proof of concept that PAL has the ability to eradicate or reduce the bacterial load of H. pylori in humans.",[130,131,132,133,134],"Helicobacter Pylori Infection","Helicobacter Pylori","Helicobacter Pylori Gastrointestinal Tract Infection","H. Pylori Infection","H. Pylori Gastrointestinal Disease",[136,137,43,138,139],"Urea Breath Test","Argon Plasma Coagulation (APC)","Plasma Activated Liquid (PAL)","Plasma Medicine","2026-02-26",{"date":142,"type":51},"2026-03-02",{"date":144,"type":51},"2025-07-08",{"date":146,"type":21},"2027-12",{"name":57,"class":58},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":159,"phases":4,"briefSummary":160,"conditions":161,"keywords":165,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":181,"locationsCount":59},"100493945","efficacy-and-safety-of-endoscopic-antral-myotomy-as-a-novel-weight-loss-procedure-100493945","NCT05711758","Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure","Efficacy and Safety of Endoscopic Antral Myotomy as a Novel Weight Loss Procedure: A Pilot Study","PSAM","Inclusion Criteria:\n\n* subjects must be 18-70 years of age\n* eligible for endoscopic and surgical weight loss procedures\n* body mass index (BMI) greater than 35 kg\u002Fm2\n* Individuals must be in excellent mental health\n* able to understand and sign informed consent\n* available to return for all routine follow-up study visits\n\nExclusion Criteria:\n\n* untreated H. pylori infection\n* gastroparesis\n* active smoking\n* an ongoing or a history of treatment with opioids in the last 12 months prior to enrollment\n* previous pyloromyotomy or pyloroplasty\n* gastrointestinal obstruction\n* severe coagulopathy\n* esophageal or gastric varices and\u002For portal hypertensive gastropathy\n* pregnancy or puerperium\n* any inflammatory disease of the gastrointestinal tract (including but not limited to severe (LA Grade C or D) esophagitis, active gastric ulceration, active duodenal ulceration, or specific inflammation such as Crohn's disease)\n* malignant or premalignant gastric diseases (such as high grade dysplasia, gastric cancer, or GIST)\n* severe cardiopulmonary disease or a history of coronary artery disease (including myocardial infarction within the past 6 months, poorly controlled hypertension, required use of NSAIDs)\n* lactation\n* history of gastrointestinal surgery\n* any serious health condition unrelated to their weight that would increase the risk of endoscopy\n* chronic abdominal pain\n* active psychological issues preventing participation in a lifestyle modification program\n* a known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)\n* an inability to provide informed consent\n* use of any medication that may interfere with weight loss\n* use of any medication that may interfere with gastric emptying\n* any other condition which the investigator may deem as an impediment to compliance or hinder completion of the proposed study","70 Years",{"count":158,"type":21},30,"OBSERVATIONAL","Gastric myotomy has been performed for several years as a means of addressing chronic stenosis after sleeve gastrectomy and treating gastroparesis. The Pylorus Sparing Antral Myotomy (PSAM) technique has the opposite effect by leaving the pylorus intact and extending the myotomy proximally to the distal gastric body. PSAM was initially combined with ESG and shown to delay gastric emptying and provide greater weight loss without impacting tolerability (GCSI score) or the safety profile of the procedure (2 DDW GEM abstracts). PSAM has not been evaluated alone, without concomitant ESG. Since delayed gastric emptying alone is known to promote weight loss, it is thought that PSAM alone (without ESG) may provide similar efficacy, while reducing procedure time and adverse events. There have been no clinical studies that investigate the efficacy of PSAM independent of ESG. This pilot study aims to address this lack of information by evaluating the safety, tolerability, and short-term efficacy of PSAM, in addition to exploring its impact on gastric physiology. This will also provide data that may be used in designing a larger clinical trial.",[104,105,162,163,164],"Obesity, Primary","Metabolic Disease","Delayed Gastric Emptying Following Procedure",[166,167,168,169,170,171,172,173,174,175,176],"Pylorus Sparing Antral Myotomy (PSAM)","Gastric physiology","Gastric emptying","Pylorus-sparing antral myotomy","Myotomy","Endoscopic Sleeve Gastroplasty (ESG)","TransPyloric Shuttle (TPS)","Intragastric balloon (IGB)","Endoscopic bariatric and metabolic therapies (EBMT)","Gut Hormones","Gastric Emptying Breath Test",{"date":142,"type":51},{"date":179,"type":51},"2023-09-22",{"date":146,"type":21},{"name":57,"class":58},""]