Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-30 @ 9:03 PM
Study NCT ID:
NCT06925256
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-13
First Post:
2025-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Considering Peripheral Nerve Injury, Is It Safe to Perform Transradial Angiography?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000092184', 'term': 'Nerve Conduction Studies'}], 'ancestors': [{'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-03-25', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nerve conduction studies (NCS)', 'timeFrame': '1 day', 'description': 'NCS (Nerve conduction study) findings obtained after radial intervention A NCS test measures how fast an electrical impulse moves through your nerve. NCS can identify nerve damage. During the test, your nerve is stimulated, often with electrode patches put on your skin. Two electrodes are placed on the skin over your nerve or over a muscle. One electrode stimulates your nerve with a very mild electrical impulse. The other electrode records it. The resulting electrical activity is recorded by another electrode. This is repeated for each nerve being tested. After test below values are obtained;\n\n* Velocity (meter/second),\n* Action potential amplitude (miliVolt)\n* Onset latans (milisecond)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nerve Conduction Studies', 'Nerve damage', 'Transradial angiography'], 'conditions': ['Neuropathic Peripheral Pain']}, 'descriptionModule': {'briefSummary': 'So far, apart from a limited number of case reports and small-scale studies, the frequency and severity of this complication have not been objectively evaluated using electromyography (EMG). In this study, presence, severity, and extent of nerve injury (one of the potential complications following the transradial approach (TRA)) were evaluated by EMG studies in patients managed at Bursa City Hospital.', 'detailedDescription': 'Evaluation of peripheral nerve injury after transradial angiography with nerve conduction studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n20-60 years old patiens who applied trans angiograhy were included to study\n\nExclusion Criteria:\n\n* Having cognitive disorders\n* Patients who have story of cardiac pace / ICD,\n* History of polyneuropathy,\n* Previous nerve damages,\n* Deformities on arm,\n* Plexopathy,\n* Radiculopathy,\n* Spinal surgery.\n* Having medical treatment for any kind of neuropathy\n* Having Cognitive disorders'}, 'identificationModule': {'nctId': 'NCT06925256', 'briefTitle': 'Considering Peripheral Nerve Injury, Is It Safe to Perform Transradial Angiography?', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bursa City Hospital'}, 'officialTitle': 'Considerin Peripheral Nerve Injury, Is It Safe to Perform Transradial Angiography?', 'orgStudyIdInfo': {'id': '2025-PMR-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with transradial angiography', 'description': 'all patients involved evaluated with NCS', 'interventionNames': ['Diagnostic Test: nerve conduction study']}], 'interventions': [{'name': 'nerve conduction study', 'type': 'DIAGNOSTIC_TEST', 'description': 'median ulnar and radial motor- sensory nerve conduction studies will be performed.', 'armGroupLabels': ['Patients with transradial angiography']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Taner Dandinoglu, MD.', 'role': 'CONTACT', 'email': 'dandinoglu@gmail.com', 'phone': '90 533 691 4066'}, {'name': 'Selma Kızıltoprak, MD.', 'role': 'CONTACT', 'email': 'selmasimsek1996@gmail.com', 'phone': '90 534 855 6211'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'upon reasonable request will be provided by the authors'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bursa City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PM&R physician', 'investigatorFullName': 'Taner Dandinoğlu', 'investigatorAffiliation': 'Bursa City Hospital'}}}}