Ignite Creation Date:
2025-12-24 @ 9:38 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT06715332
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Procedure time', 'timeFrame': '1 day', 'description': 'Duration of ESD'}, {'measure': 'Device dysfunction', 'timeFrame': '1 day', 'description': 'Failure of device to continue the procedure'}, {'measure': 'Need for change to other device', 'timeFrame': '1 day', 'description': 'Rate of changing to other ESD knife'}], 'primaryOutcomes': [{'measure': 'En-bloc resection rate', 'timeFrame': '30 days', 'description': 'Defined by complete macroscopic resection of the target neoplasia in one single specimen'}], 'secondaryOutcomes': [{'measure': 'R0 resection rate', 'timeFrame': '30 days', 'description': 'Defined by histologically margin negative resection (Both horizontal and vertical margins)'}, {'measure': 'Curative resection rate', 'timeFrame': '30 days', 'description': 'Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines'}, {'measure': 'Adverse event rate', 'timeFrame': '30 days', 'description': 'Overall adverse event rate, according to ASGE lexicon'}, {'measure': 'Rate of adverse event - hemorrhage', 'timeFrame': '30 days', 'description': 'Rate of intraprocedural and post procedural delayed hemorrhage'}, {'measure': 'Rate of adverse event - perforation', 'timeFrame': '30 days', 'description': 'Rate of intraprocedural and post procedural delayed perforation'}, {'measure': 'Rate of adverse event - post-ESD coagulation syndrome', 'timeFrame': '30 days', 'description': 'Defined by post-procedural abdominal pain and systemic inflammatory response'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endoscopic submucosal dissection'], 'conditions': ['Colon Polyp', 'Colon Neoplasia']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This is a prospective study with the following study Objectives:\n\n1. To evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD.\n2. To assess the impact of the procedure on patient recovery time and postoperative adverse event.\n\nThis 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. Patients will undergo a ESD for superficial colorectal neoplasia. All ESD procedures will be performed by expert endoscopists with at least 50 prior experience of ESD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 \\< 50000/µl.'}, 'identificationModule': {'nctId': 'NCT06715332', 'briefTitle': 'Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study', 'orgStudyIdInfo': {'id': 'CRE-2024.495'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endoscopic submucosal dissection with SpydrBlade Flex', 'description': 'This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife', 'interventionNames': ['Device: Colorectal ESD with SpydrBlade Flex']}], 'interventions': [{'name': 'Colorectal ESD with SpydrBlade Flex', 'type': 'DEVICE', 'description': "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.", 'armGroupLabels': ['Endoscopic submucosal dissection with SpydrBlade Flex']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Hon Chi Yip, MBChB', 'role': 'CONTACT', 'email': 'hcyip@surgery.cuhk.edu.hk', 'phone': '35052627'}], 'overallOfficials': [{'name': 'Hon Chi Yip, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hon Chi Yip', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}