Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-30 @ 1:10 PM
Study NCT ID:
NCT05017350
Status:
UNKNOWN
Last Update Posted:
2021-08-23
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemostasis Using Radiofrequency Ablation for Track Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-17', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-17', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemostasis rate', 'timeFrame': 'immediately after radiofrequency ablation', 'description': 'success rate of hemostasis using radiofrequency ablation on CT taken after radiofrequency ablation'}], 'secondaryOutcomes': [{'measure': 'complication rate', 'timeFrame': 'immediately after radiofrequency ablation', 'description': 'complication rate associated with radiofrequency ablation on CT taken after radiofrequency ablation'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['liver', 'track bleeding', 'radiofrequency ablation'], 'conditions': ['Bleeding']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding that has occurred after percutaneous biopsy of the liver.', 'detailedDescription': 'Purpose: To evaluate the usefulness of hemostasis using radiofrequency ablation for track bleeding after percutaneous liver biopsy.\n\nMethod:\n\n* Enroll patients who continue to bleed despite conservative treatment for track bleeding that has occurred after liver biopsy.\n* Radiofreqeuncy ablation: Under monitoring vital signs and controlling pain with intravenous agents, the electrode is inserted into the bleeding focus. The bleeding focus is ablated.\n* Hemostasis is evaluated by ultrasound (right after radiofrequency ablation), CT scan (after the radiofrequency ablation), and ultrasound (the day after radiofrequency ablation)\n* If hemostasis fails using radiofrequency ablation, transarterial hepatic embolization is performed immediately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ultrasound guided percutaneous liver biopsy at Samsung Medical Center\n* Track bleeding after biopsy\n* Persistent track bleeding even after conservative management\n* Consent to this study\n\nExclusion Criteria:\n\n* Not consent to this study\n* \\<20 years old or \\>=80 years old\n* Contraindication to radiofrequency ablation\n* Radiofrequency ablation for track bleeding is not technically possible.\n* Unstable vital signs'}, 'identificationModule': {'nctId': 'NCT05017350', 'briefTitle': 'Hemostasis Using Radiofrequency Ablation for Track Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Hemostasis Using Radiofrequency Ablation for Track Bleeding After Liver Biopsy', 'orgStudyIdInfo': {'id': '2021-04-028-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency ablation group', 'description': 'hemostasis using radiofrequency ablation for track bleeding', 'interventionNames': ['Procedure: radiofrequency ablation']}], 'interventions': [{'name': 'radiofrequency ablation', 'type': 'PROCEDURE', 'description': 'Under the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated.', 'armGroupLabels': ['Radiofrequency ablation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Kyoung Doo Song, Professor', 'role': 'CONTACT', 'email': 'kd3893.song@samsung.com'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Kyoung Doo Song, Professor', 'role': 'CONTACT', 'email': 'kd3893.song@samsung.com', 'phone': '82-2-3410-2518'}, {'name': 'Min Woo Lee, Professor', 'role': 'CONTACT', 'email': 'mw2542.lee@samsung.com'}], 'overallOfficials': [{'name': 'Kyoung Doo Song, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyoung Doo Song', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Kyoung Doo Song', 'investigatorAffiliation': 'Samsung Medical Center'}}}}