Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:46 AM
Study NCT ID:
NCT07436559
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AVF Stenosis by Electronic Stethoscope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D001164', 'term': 'Arteriovenous Fistula'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AVF stenosis', 'timeFrame': 'From enrollment to the end of study at 3 months', 'description': 'Clinical stenosis: Diagnosed by attending nephrologist based on physical examination abnormalities (high-pitched bruit, pulsatile flow, diminished thrill) - Confirmed by Doppler ultrasound showing \\>50% diameter reduction - Intervention: Percutaneous transluminal angioplasty (PTA)'}], 'secondaryOutcomes': [{'measure': 'Abnormal AVF sound threshold', 'timeFrame': 'From enrollment to the end of study at 3 months', 'description': 'Defined using statistical analysis of post-PTA normal sounds'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis, Electronic Stethoscope, Arteriovenous Fistula, Regression Analysis'], 'conditions': ['End Stage Renal Disease (ESRD)']}, 'descriptionModule': {'briefSummary': 'The prevalence rate of hemodialysis in Taiwan is the highest in the world, and the number of new cases of hemodialysis and the death rate are gradually increasing every year. Long-term hemodialysis patients must receive dialysis through the arteriovenous fistula. If the arteriovenous fistula is narrowed, the dialysis effect will be poor or the dialysis will not be possible due to blockage, resulting in complications and mortality. The detection of the arteriovenous fistula must rely on the assistance of professionals.\n\n\\* Is it easier for clinicians to detect arteriovenous fistula stenosis by an electronic stethoscope?\n\nThis study uses an electronic stethoscope to take the hemodialysis center of Douliu District, Yunlin Branch of National Taiwan University Hospital as the experimental site. Select 30 patients who need long-term dialysis, adults (20-99 years old) who have been on dialysis for more than 3 months and have arteriovenous fistula. The experiment period lasted for 3 months, and each person received 2-3 voices per week, about 1080 voices. The main purpose is to use the electronic stethoscope and the experience of traditional professionals, hoping to detect and predict the stenosis in advance. The important key factors of vascular access stenosis in hemodialysis patients were found through regression analysis of the Albumin value and clinical data obtained from routine treatment of patients of a fixed blood test in monthly hemodialysis center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'End stage renal disease patients received hemodialysis for more than 3 months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 20-99 years - Chronic hemodialysis ≥3 months - Functional arteriovenous fistula (AVF) - Ability to provide informed consent\n\nExclusion Criteria:\n\n* Arteriovenous graft (AVG) - Central venous catheter (Permcath) - Vulnerable populations unable to consent'}, 'identificationModule': {'nctId': 'NCT07436559', 'briefTitle': 'AVF Stenosis by Electronic Stethoscope', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Detection and Prediction of the Stenosis of Arteriovenous Fistula in Hemodialysis Patients by an Electronic Stethoscope', 'orgStudyIdInfo': {'id': '202302099RINA'}, 'secondaryIdInfos': [{'id': 'AVF stenosis detection', 'type': 'OTHER', 'domain': 'National Taiwan University Hospital Yunlin Branch'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Detection and Prediction of the stenosis of arteriovenous fistula in hemodialysis patients by an electronic stethoscope', 'type': 'DEVICE', 'description': 'The detection of the arteriovenous fistula must rely on the assistance of professionals by palpation or a conventional stethoscope. This study will investigate the detection and prediction of arteriovenous fistula stenosis in hemodialysis patients by an electronic stethoscope.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '640', 'city': 'Douliu', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital Yunlin Branch', 'geoPoint': {'lat': 23.70944, 'lon': 120.54333}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}