[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642036":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":62,"collaborators":20,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":20,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ESG plus duodenal pulsENDO","EXPERIMENTAL","ESG and pulsENDO procedure will be performed in same session",[13],"Procedure: Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Endoscopic sleeve gastroplasty plus duodenal recellularization via electroporation therapy (pulsENDO)","First part - pulsENDO procedure :\n\nThe 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.\n\nSecond part - Endoscopic sleeve gastroplasty :\n\nESG is performed using an endoscopic suturing device (Overstitch, BSC) to reduce the stomach volume through the creation of a restrictive endoscopic sleeve. This is accomplished with around 4-7 permanent full thickness sutures over greater curve stomach in a running plication extending from the angular incisura and continuing proximally with fundal sparing.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Stephen Ng","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},"Ivy Study coordinator","ivypoon@surgery.cuhk.edu.hk",[35],{"facility":24,"status":36,"city":37,"state":20,"zip":20,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Shatin","Hong Kong","HK",{"type":41,"coordinates":42},"Point",[43,44],114.18333,22.38333,{"lat":44,"lon":43},[47,49,51,54,56,58,60],{"name":48,"role":28,"phone":29,"phoneExt":20,"email":30},"Stephen Ng, FRCSEd(Gen)",{"name":50,"role":28,"phone":29,"phoneExt":20,"email":33},"Ivy Poon",{"name":52,"role":53,"phone":20,"phoneExt":20,"email":20},"Philip Chiu, MD","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":20,"phoneExt":20,"email":20},"Alice Kong, MD",{"name":57,"role":53,"phone":20,"phoneExt":20,"email":20},"Derek Xia, PhD(CUHK)",{"name":59,"role":53,"phone":20,"phoneExt":20,"email":20},"Raymond Tang, MD",{"name":61,"role":53,"phone":20,"phoneExt":20,"email":20},"Jimmy Lai",{"type":25,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Stephen KK Ng","Principal Investigator","100642036","endoscopic-sleeve-gastroplasty-plus-duodenal-pulsendo-for-obese-t2dm-100642036",false,"NCT07660445","Endoscopic Sleeve Gastroplasty Plus Duodenal pulsENDO for Obese T2DM","Integrating Duodenal Recellularization Via Electroporation Therapy and Endoscopic Sleeve Gastroplasty as a Novel Approach to Managing Diabesity (DRAGON Study)","DRAGON","Inclusion Criteria:\n\n* BMI \\>\u002F= 27kg\u002Fm2\n* Known T2DM\n* Individualized Metabolic Surgery (IMS) score 25-115\n* HbA1c \\\u003C11% (subjects on oral glucose lowering drug(s) or HbA1c \\\u003C8% (subjects on insulin)\n\nExclusion Criteria:\n\n* Previous treatment with ReCET, ESG or similar procedure\n* Previous GI surgery that could preclude the ability to perform ReCET or ESG, or acute gastric and duodenal pathology that increased the risk of ReCET or ESG\n* Type 1 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 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":77,"type":78},20,"ESTIMATED","INTERVENTIONAL",[81],"NA","This study is designed to evaluate the efficacy, safety, and mechanisms of combining ESG and pulsENDO procedure in obese patients with T2DM",[84],"Obesity Type 2 Diabetes Mellitus","2026-06-20",{"date":87,"type":88},"2026-06-24","ACTUAL",{"date":90,"type":78},"2026-08-01",{"date":92,"type":78},"2031-07-31",{"name":5,"class":6},1]