Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-25 @ 1:29 AM
Study NCT ID:
NCT06714292
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-11-25', 'studyFirstSubmitQcDate': '2024-11-27', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of localization', 'timeFrame': 'In operation', 'description': 'Accuracy of Identifying the Exact Tumor Location\n\nExperimental Group: Considered successful when the tumor can be observed through the applied clips using fluorescence imaging.\n\nControl Group: Considered successful when the ICG-tattooed tumor can be observed.'}], 'secondaryOutcomes': [{'measure': 'Reconfirmation Rate via Intraoperative Colonoscopy (%)', 'timeFrame': 'In operation', 'description': 'The proportion of cases where intraoperative colonoscopy was performed.'}, {'measure': 'Total Operation Time (minutes)', 'timeFrame': 'From start of operation to end of operation.', 'description': 'The time from skin incision to skin closure.'}, {'measure': 'Time Required for Endoscopic Marking Procedure (minutes)', 'timeFrame': 'From identifying of tumor in colonoscopy to completing the clipping or injection of ICG', 'description': 'The time from identifying the tumor to completing the attachment of all required clips for marking the tumor or completing the injection of ICG.'}, {'measure': 'Longitudinal Length of ICG Spread in the Control Group (mm)', 'timeFrame': 'After resection of colon, in operation', 'description': 'In ICG group, measure the length of tattooed area using a disposable paper ruler on the serosa side of colon.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tattooing', 'localization', 'colon cancer'], 'conditions': ['Colon Cancer']}, 'descriptionModule': {'briefSummary': '* Title of the Study Testing a Fluorescent Surgical Marker Clip for Tumor Localization in Minimally Invasive Colorectal Surgery\n* Purpose of the Study This study aims to determine if a fluorescent surgical marker clip can accurately and safely localize tumor locations in the colon during minimally invasive colorectal surgery. The study will compare the effectiveness of this clip to the current method using a dye called Indocyanine Green (ICG).\n\nThe main questions the investigators aim to address are:\n\nCan the clip safely and effectively localize tumor sites compared to ICG dye? What side effects or medical issues might arise with the use of the clip?\n\n-Study Design Assignment\n\nParticipants will be randomly assigned to one of two groups:\n\nThe clip group: A fluorescent clip will be placed near the tumor. The dye group: ICG dye will be injected near the tumor.\n\nProcedures Participants will undergo a colonoscopy to mark the tumor location before surgery using either the fluorescent clip or ICG dye.\n\n* Follow-Up Participants will attend follow-up visits after surgery to monitor for any side effects or complications.\n* Eligibility Inclusion Criteria\n\nParticipants may qualify if:\n\nThey are 19 years or older. They are scheduled for minimally invasive colorectal surgery for a tumor or suspected tumor.\n\nExclusion Criteria\n\nParticipants cannot enroll if:\n\nThey have certain medical conditions, such as blood clotting disorders or allergies to metals or iodine.\n\nThey are pregnant or breastfeeding.\n\n-Participant Role By participating, individuals will contribute to advancing research aimed at improving methods for tumor localization during surgery, potentially leading to enhanced surgical outcomes in the future.\n\nFor questions or concerns, participants are encouraged to contact the investigators or the research team.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 19years or more\n* With colonic neoplasm planning minimally invasive surgery\n* Need localization of lesion before surgery\n\nExclusion Criteria:\n\n* Planned total proctocolectomy\n* Contraindication of colonoscopy\n* On pregnancy or breast-feeding'}, 'identificationModule': {'nctId': 'NCT06714292', 'acronym': 'FLARECLIP', 'briefTitle': 'Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Efficacy and Safety of Fluorescent Surgical Marker Clip for Tumor Localization in Laparoscopic Colorectal Surgery for Colorectal Cancer Patients : Multi-center, Randomized, Single-blind, Prospective, Non-Inferiority Trial', 'orgStudyIdInfo': {'id': 'KSC-CRC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clip group', 'description': 'Patients who are underwent localization of colon lesion with fluorescent clip', 'interventionNames': ['Procedure: Endoscopic Clipping']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ICG group', 'description': 'Patients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method', 'interventionNames': ['Procedure: ICG injection']}], 'interventions': [{'name': 'Endoscopic Clipping', 'type': 'PROCEDURE', 'description': 'localization of colon lesion with fluorescent clip', 'armGroupLabels': ['Clip group']}, {'name': 'ICG injection', 'type': 'PROCEDURE', 'otherNames': ['ICG tattooing'], 'description': 'localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing', 'armGroupLabels': ['ICG group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10408', 'city': 'Goyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'National Cancer Center', 'geoPoint': {'lat': 37.65639, 'lon': 126.835}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Boramae Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ji Won Park, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}