[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622961":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":61,"collaborators":20,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":20,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":20,"overallStatus":86,"whyStopped":20,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic duodenal recellularization via electroporation therapy (pulsENDO)","EXPERIMENTAL","pulsENDO procedure entails the ablation of the duodenal mucosa with irreversible electroporation (IRE)",[13],"Procedure: pulsENDO treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","pulsENDO treatment","The pulsENDO procedure utilizes the pulsENDO catheter to deliver non-thermal pulsed electric field to the duodenum to induce cell regeneration. The catheter is introduced to the duodenum through the mouth using a guide wire and the therapy is applied to treat the duodenum under endoscopic visualisation, starting from D4 and repeated proximally. Approximately 10-18 cm of axial length of the duodenum is treated.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Stephen Ng, FRCSEd(Gen)","Prince of Wales Hospital, the Chinese University of Hong Kong","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+85235052956","stephenng@surgery.cuhk.edu.hk",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Jenny Study coordinator","jennyho@surgery.cuhk.edu.hk",[35],{"facility":5,"status":20,"city":36,"state":20,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Shatin","Hong Kong","HK",{"type":40,"coordinates":41},"Point",[42,43],114.18333,22.38333,{"lat":43,"lon":42},[46,47,49,50,53,55,57,59],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":48,"role":28,"phone":29,"phoneExt":20,"email":33},"Jenny Ho",{"name":23,"role":25,"phone":20,"phoneExt":20,"email":20},{"name":51,"role":52,"phone":20,"phoneExt":20,"email":20},"Philip Chiu, FRCSEd(Gen), MD","SUB_INVESTIGATOR",{"name":54,"role":52,"phone":20,"phoneExt":20,"email":20},"Alice Kong, MD",{"name":56,"role":52,"phone":20,"phoneExt":20,"email":20},"Raymond Tang, MD",{"name":58,"role":52,"phone":20,"phoneExt":20,"email":20},"Derek Xia, PhD(CUHK)",{"name":60,"role":52,"phone":20,"phoneExt":20,"email":20},"Jimmy Lai, FRCP(Edin)",{"type":25,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Stephen KK Ng","Principal Investigator","100622961","duodenal-pulsendo-for-suboptimally-controlled-type-ii-diabetes-mellitus-and-steatotic-liver-disease-100622961",false,"NCT07390422","Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease","Duodenal Recellularization Via Electroporation Therapy for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1 Study)","DRESS-1","Inclusion Criteria:\n\n* Duration of T2DM \\\u003C 10 years\n* BMI 18.5-40kg\u002Fm2\n* Failure to achieve adequate HbA1c reduction (7.5 - 11%) after at least 3 months stable dosage of oral glucose lowering drugs\n\nExclusion Criteria:\n\n* Previous treatment with pulsENDO or similar procedure\n* Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO\n* Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis\n* Patients on insulin\n* Fasting C-peptide level \\\u003C0.5ug\u002FL\n* Any inflammatory disease of the gastrointestinal tract such as Crohn's disease\n* Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study\n* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000\u002Fmicroliter or known coagulopathy\n* Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to study and\u002For there is a need or expected need to use during the study period\n* Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)\n* Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month\n* Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.\n* Patients with contra-indications to endoscopy\n* Patients with cirrhosis due to causes other than MASLD\n* Malignancy\n* Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)\n* Pregnant or breast feeding\n* ASA grade IV \\& V\n* Mental or psychiatric disorder; Drug or alcohol addiction\n* Other cases deemed by the examining physician as unsuitable for safe treatment\n* Refusal to participate","ALL","18 Years","70 Years",{"count":76,"type":77},40,"ESTIMATED","INTERVENTIONAL",[80],"NA","This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.",[83,84,85],"T2DM (Type 2 Diabetes Mellitus)","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Syndrome (MetS)","NOT_YET_RECRUITING","2026-06-20",{"date":89,"type":90},"2026-06-24","ACTUAL",{"date":92,"type":77},"2026-09-01",{"date":94,"type":77},"2033-08-30",{"name":5,"class":6},1]