Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-31 @ 7:36 AM
Study NCT ID:
NCT02758535
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2016-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Renal Parenchymal Core Needle Biopsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 166}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-29', 'studyFirstSubmitDate': '2016-04-29', 'studyFirstSubmitQcDate': '2016-04-29', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complication ratio', 'timeFrame': 'within 48 hours after the procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Image-guided Biopsy', 'Complications', 'Kidney Glomerulus']}, 'descriptionModule': {'briefSummary': 'Percutaneous image-guided parenchymal renal biopsy has been used to detect the different pathologies of renal parenchyma, to define the degree of reversible changes, and to define when the medical treatment fails. Percutaneous core needle renal biopsy has been reported to have a higher diagnostic yield compared to fine needle aspiration. Percutaneous core needle renal biopsy is usually based on tissue sampling under guidance of either sonography or computed tomography. Renal parenchymal biopsy can be done either with a coaxial or noncoaxial technique. In coaxial technique, the introducing needle is placed in the renal parenchyma; then, multiple tissue sampling can be performed throughout the same tract. Alternatively, in noncoaxial technique, biopsy needle is inserted repeatedly for each tissue sampling. Although there are some reports regarding the comparison of coaxial and noncoaxial methods of renal mass biopsy, comparison of the two methods in renal parenchymal biopsy has not yet been described in the literature. In this prospective study, the investigators sought to compare the procedural time and the complication rate of coaxial technique with those of noncoaxial technique in percutaneous renal parenchymal biopsy.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* impaired renal function\n* proteinuria\n* hematuria\n\nExclusion Criteria:\n\n* renal hydronephrosis\n* chronic renal failure\n* a history of renal cell carcinoma\n* suspicious renal mass\n* uncorrectable coagulopathy'}, 'identificationModule': {'nctId': 'NCT02758535', 'briefTitle': 'Renal Parenchymal Core Needle Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Modarres Hospital'}, 'orgStudyIdInfo': {'id': 'Renal Parenchymal Biopsy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Core needle biopsy with coaxial method', 'description': 'The patients undergo renal biopsy with a coaxial Tru-Cut needle', 'interventionNames': ['Device: coaxial renal biopsy']}, {'type': 'EXPERIMENTAL', 'label': 'Core needle biopsy with noncoaxial method', 'description': 'The patients undergo renal biopsy with a noncoaxial Tru-Cut needle', 'interventionNames': ['Device: noncoaxial renal biopsy']}], 'interventions': [{'name': 'coaxial renal biopsy', 'type': 'DEVICE', 'otherNames': ['18-gauge semiautomatic biopsy system with the coaxial needle; Tasuku Laboratory, Tochigi, Japan'], 'description': 'In this method, a larger introducing needle is used for the puncture. The introducing needle is advanced just to the outer cortex of the kidney, and the needle angle is adjusted so that the needle pathway became mostly in the renal cortex, then the biopsy needle is inserted throughout the introducing needle and at least 4 cores are obtained. In this technique, the skin surface is punctured only once during the procedure.', 'armGroupLabels': ['Core needle biopsy with coaxial method']}, {'name': 'noncoaxial renal biopsy', 'type': 'DEVICE', 'otherNames': ['18-gauge semiautomatic biopsy system without coaxial needle; Tasuku Laboratory, Tochigi, Japan'], 'description': 'In this method, introducing needle is not used. Biopsy needle punctures the skin surface and the needle is advanced to about 10-15 mm into the renal cortex, and tissue sampling is done. After each sampling, the needle is removed and then for the next biopsy, the whole procedure is repeated until four cores being taken.', 'armGroupLabels': ['Core needle biopsy with noncoaxial method']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rasht', 'state': 'Gilan Province', 'country': 'Iran', 'facility': 'Department of Radiology, Poursina Hospital, Guilan University of Medical Sciences', 'geoPoint': {'lat': 37.27611, 'lon': 49.58862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Modarres Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}