[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571060":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":41,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":20,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":66,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Endoscopic submucosal dissection with SpydrBlade Flex","EXPERIMENTAL","This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife",[13],"Device: Colorectal ESD with SpydrBlade Flex",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Colorectal ESD with SpydrBlade Flex","The allocated intervention would be performed under sedation or monitored anaesthesia by experienced endoscopists with at least 50 case experience of colon ESD.\n\nColon ESD procedure would be performed as per described in the literature. After submucosal injection of solution to create a cushion, mucosal incision and submucosal dissection would be performed with the SydrBlade Flex. Submucosal plane dissection will be performed using the SpydrBlade Flex (BRF, cutting frequency 400kHz, power setting 35W). The exact resection strategy would be according to the endoscopists' preference, including different adjunctive techniques such as countertraction, tunnelling or pocket creation method. Upon completion of ESD, the resultant mucosal defect would be examined for any perforation or bleeding.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Hon Chi Yip, MBChB","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","35052627","hcyip@surgery.cuhk.edu.hk",[31],{"facility":32,"status":20,"city":33,"state":20,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":20},"The Chinese University of Hong Kong","Hong Kong","HK",{"type":36,"coordinates":37},"Point",[38,39],114.17469,22.27832,{"lat":39,"lon":38},{"type":24,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Hon Chi Yip","Assistant Professor","100571060","prospective-study-of-using-novel-bipolar-scissors-in-colorectal-endoscopic-submucosal-dissection-100571060",false,"NCT06715332","Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection","Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study","Inclusion criteria:\n\n* Adult patient (age ≥18 and ≤80 years-old)\n* Capability of understanding and complying with the study requirements, including signing the informed consent form.\n* Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).\n\nExclusion criteria:\n\n* Patients unable or unwilling to provide consent.\n* Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.\n* Patients with lesions involving the appendiceal orifice or ileocaecal valve.\n* Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure.\n* Poor performance status (Eastern Cooperation Oncology Group performance status ≥3).\n* Pregnant women or those planning pregnancy or breastfeeding women.\n* Uncorrectable coagulopathy defined by international normalized ratio (INR) \\> 1.5 or platelet count \\\u003C 50000\u002Fµl.","ALL","18 Years","80 Years",{"count":55,"type":56},30,"ESTIMATED","INTERVENTIONAL",[59],"NA","This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia.",[62,63],"Colon Polyp","Colon Neoplasia",[65],"Endoscopic submucosal dissection","NOT_YET_RECRUITING","2024-11-29",{"date":69,"type":70},"2024-12-04","ACTUAL",{"date":72,"type":56},"2024-12-08",{"date":74,"type":56},"2026-03-31",{"name":5,"class":6},1]