Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
Study NCT ID:
NCT06600750
Status:
COMPLETED
Last Update Posted:
2024-09-26
First Post:
2024-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Artificial Intelligence-based Prediction of Radio-cephalic Arteriovenous Fistula Maturation Using Preoperative Duplex Examination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001165', 'term': 'Arteriovenous Malformations'}, {'id': 'D054079', 'term': 'Vascular Malformations'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016157', 'term': 'Vascular Fistula'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001166', 'term': 'Arteriovenous Shunt, Surgical'}], 'ancestors': [{'id': 'D000714', 'term': 'Anastomosis, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D058017', 'term': 'Vascular Grafting'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 494}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2024-09-16', 'studyFirstSubmitQcDate': '2024-09-16', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maturation of the fistula', 'timeFrame': '90 days', 'description': 'Fistula maturation was defined as an arteriovenous fistula that matures and is usable for dialysis with two-needle cannulation for hemodialysis for at least 90 days without the need for endovascular or surgical interventions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preoperative Ultrasound Mapping', 'Radiocephalic Arteriovenous Fistula', 'Renal Dialysis', 'Artificial intelligence', 'Machine Learning', 'Chronic Kidney Disease'], 'conditions': ['Renal Insufficiency, Chronic', 'Arteriovenous Fistula', 'Artificial Intelligence (AI)', 'Machine Learning']}, 'referencesModule': {'references': [{'pmid': '25736517', 'type': 'BACKGROUND', 'citation': 'Georgiadis GS, Charalampidis DG, Argyriou C, Georgakarakos EI, Lazarides MK. The Necessity for Routine Pre-operative Ultrasound Mapping Before Arteriovenous Fistula Creation: A Meta-analysis. Eur J Vasc Endovasc Surg. 2015 May;49(5):600-5. doi: 10.1016/j.ejvs.2015.01.012. Epub 2015 Feb 27.'}, {'pmid': '16813991', 'type': 'BACKGROUND', 'citation': 'Vascular Access Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S248-73. doi: 10.1053/j.ajkd.2006.04.040. No abstract available.'}, {'pmid': '14727162', 'type': 'BACKGROUND', 'citation': 'Perera GB, Mueller MP, Kubaska SM, Wilson SE, Lawrence PF, Fujitani RM. Superiority of autogenous arteriovenous hemodialysis access: maintenance of function with fewer secondary interventions. Ann Vasc Surg. 2004 Jan;18(1):66-73. doi: 10.1007/s10016-003-0094-y. Epub 2004 Jan 20.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess the efficacy of AI-driven models in analyzing comprehensive ultrasonographic variables across multiple forearm locations to predict successful AVF maturation. The main question it aims to answer is:\n\nCan AI-driven models analyzing comprehensive ultrasonographic variables accurately predict the successful maturation of arteriovenous fistulas (AVFs)?\n\nParticipants who underwent radiocephalic arteriovenous fistula (AVF) creation had their preoperative ultrasonographic data analyzed using AI-driven models to predict successful AVF maturation over a four-year retrospective period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022\n\nExclusion Criteria:\n\n* Patients who did not have follow-up data available'}, 'identificationModule': {'nctId': 'NCT06600750', 'briefTitle': 'Artificial Intelligence-based Prediction of Radio-cephalic Arteriovenous Fistula Maturation Using Preoperative Duplex Examination', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Artificial Intelligence-based Prediction of Radio-cephalic Arteriovenous Fistula Maturation Using Preoperative Duplex Examination', 'orgStudyIdInfo': {'id': 'S2020-3118-0001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease', 'description': 'Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease', 'interventionNames': ['Procedure: Arteriovenous fistula']}], 'interventions': [{'name': 'Arteriovenous fistula', 'type': 'PROCEDURE', 'description': 'Patients who underwent Radiocephalic arteriovenous fistula surgery', 'armGroupLabels': ['Patients who underwent radiocephalic arteriovenous fistula due to advanced chronic kidney disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ara Cho', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}