Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT04458233
Status:
UNKNOWN
Last Update Posted:
2020-07-07
First Post:
2020-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-30', 'studyFirstSubmitDate': '2020-06-30', 'studyFirstSubmitQcDate': '2020-06-30', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of FNAC non diagnostic Bethesda 1 results', 'timeFrame': '1 year', 'description': 'The exact preferred technique for performing Ultrasound Guided FNA is unclear. The correct positioning of the US probe and or the FNA needle could have a marked effect on the diagnostic results of the biopsy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Nodule']}, 'descriptionModule': {'briefSummary': 'Ultrasound-guided fine needle aspiration cytology (FNAC) has been proven to be an accurate and efficient tool in thyroid nodule evaluation. Thyroid nodule aspiration is performed by the use of either two techniques; the short axis approach by which only the tip of the needle is observed, or the long axis approach by which the entire needle is observed. Controversial remains of which approach produces better diagnostic adequacy and less non-diagnostic (Bethesda category I) results.', 'detailedDescription': '200 patients presenting electively for thyroid FNA will recruited. Patients will be randomly assigned to two groups: short axis or long axis FNA. FNA will be performed by a single physician at the Ziv medical center ENT clinics.\n\npatient group randomization will be performed according to a random number sequence generated by the SPSS system. Randomization will be performed on admission prior to the procedure.\n\nFNAC sample diagnosis will be performed according to the regular protocol. Laboratory personnel will be blinded to the sample group.\n\nsample results will be compared and analyzed. A P value of less than 0.05 will be regarded as significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected thyroid nodule requiring diagnostic FNA,\n\nExclusion Criteria:\n\n* under or above age limit, no informed consent'}, 'identificationModule': {'nctId': 'NCT04458233', 'briefTitle': 'FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ziv Hospital'}, 'officialTitle': 'FNA Guided Ultrasonography Needle Technique Axial Vs Lateral Approach Study', 'orgStudyIdInfo': {'id': '0006-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'long axis', 'interventionNames': ['Procedure: long axis FNA method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'short axis', 'interventionNames': ['Procedure: long axis FNA method']}], 'interventions': [{'name': 'long axis FNA method', 'type': 'PROCEDURE', 'otherNames': ['short axis FNA method'], 'description': '). A "long-axis" view (i.e., a longitudinal image of the needle) is obtained by placing the US probe in a parallel position relative to the course of the needle. Short-axis and long-axis views can be used for both US assistance and guidance of FNA procedure. Correspondingly, approaching the nodule with the needle from the lateral or frontal aspect results in either a long axis or short axis view of the needle on the US screen', 'armGroupLabels': ['long axis', 'short axis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Safed', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Leonid Livshits, MD', 'role': 'CONTACT', 'email': 'surger79@gmail.com'}, {'name': 'YANIV AVRAHAM', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ziv Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'centralContacts': [{'name': 'yaniv avraham', 'role': 'CONTACT', 'email': 'yanivavr1@gmail.com', 'phone': '972-4-6828894'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no individual data to be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ziv Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}