Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
Study NCT ID:
NCT06670157
Status:
RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rebleeding rate at 6 weeks after treatment for gastric fundus varicose veins in cirrhosis', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Varices Bleeding']}, 'descriptionModule': {'briefSummary': 'A single-arm exploratory clinical study design was used to evaluate the safety and efficacy of a "modified sandwich injection" of tissue glue assisted by a detachable clip for the treatment of gastric varicose veins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The subject voluntarily signs the informed consent for this experiment; According to clinical manifestation, laboratory examination, imaging examination, or liver biopsy in the diagnosis of liver cirrhosis patients; The endoscopy diagnosed gastric varices (gastroesophageal varices, gastroesophageal varices type 2 or type 1 isolated gastric varices type 1); High risk of gastric varices or has a history of gastric varices bleeding. The initial fluid resuscitation patients before or after the recovery hemodynamic stability; The age of 18 years old or more.\n\nExclusion Criteria:\n\n* \\< 18 years old; Regional portal hypertension; Always have a liver transplant, via the jugular intrahepatic portal vein system bypass or splenectomy combined varices cut-out art history; A concurrent hepatorenal syndrome and/or multiple organ failure; Significant impact on survival of malignant tumor; Pregnancy or lactation; A known allergy to iodine.'}, 'identificationModule': {'nctId': 'NCT06670157', 'briefTitle': 'Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University of Traditional Chinese Medicine'}, 'officialTitle': 'Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices Under X-ray Perspective', 'orgStudyIdInfo': {'id': 'DZQH-KYLL-24-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Detachable Clip-assisted', 'description': 'After the varicose vessel is closed with a removable titanium clamp, the more varicose target vessel is located，After the varicose vessels basically disappeared under the endoscope, the removable titanium clamp was removed', 'interventionNames': ['Other: Detachable Clip']}], 'interventions': [{'name': 'Detachable Clip', 'type': 'OTHER', 'description': 'After the varicose vessels basically disappeared under the endoscope, the removable titanium clamp was removed', 'armGroupLabels': ['Detachable Clip-assisted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yu chang, Master', 'role': 'CONTACT', 'email': 'changgyuu@163.com', 'phone': '18175226948'}], 'facility': 'Eastern Theater General Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'ji xuan, doctor', 'role': 'CONTACT', 'email': 'changgyuu@163.com', 'phone': '13140718720'}, {'name': 'yu chang, master', 'role': 'CONTACT', 'phone': '18175226948'}], 'overallOfficials': [{'name': 'ji xuan, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Theater General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yu Chang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'student', 'investigatorFullName': 'Yu Chang', 'investigatorAffiliation': 'Nanjing University of Traditional Chinese Medicine'}}}}