[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621889":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":31,"responsibleParty":54,"collaborators":20,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":20,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":20,"overallStatus":78,"whyStopped":20,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"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],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+85235052956","stephenng@surgery.cuhk.edu.hk",[32],{"facility":5,"status":20,"city":33,"state":20,"zip":20,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Shatin","Hong Kong","HK",{"type":37,"coordinates":38},"Point",[39,40],114.18333,22.38333,{"lat":40,"lon":39},[43,44,47,50,52],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":45,"role":28,"phone":29,"phoneExt":20,"email":46},"Jenny Ho","jennyho@surgery.cuhk.edu.hk",{"name":48,"role":49,"phone":20,"phoneExt":20,"email":20},"Philip Chiu, FRCSEd(Gen), MD","SUB_INVESTIGATOR",{"name":51,"role":49,"phone":20,"phoneExt":20,"email":20},"Alice Kong, FRCP(Edin), MD",{"name":53,"role":49,"phone":20,"phoneExt":20,"email":20},"Derek Xia, MD",{"type":25,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Stephen KK Ng","Principal Investigator","100621889","duodenal-pulsendo-as-an-early-treatment-for-type-2-dm-100621889",false,"NCT07376486","Duodenal pulsENDO as an Early Treatment for Type 2 DM","Duodenal Recellularization Via Electroporation Therapy as an Early Treatment for Type 2 Diabetes Mellitus (DREAM-1 Study)","DREAM-1","Inclusion Criteria:\n\n* Duration of T2DM \\\u003C\u002F= 2 years\n* HbA1c \\\u003C\u002F= 7.5%\n* On 0-1 oral diabetes medications\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 I DM, DM secondary to specific disease or having any history of ketoacidosis\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* 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","60 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).",[76,77],"Diabete Mellitus","T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)","NOT_YET_RECRUITING","2026-06-20",{"date":81,"type":82},"2026-06-24","ACTUAL",{"date":84,"type":70},"2026-09-01",{"date":86,"type":70},"2032-08-30",{"name":5,"class":6},1]