Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT01692405
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2012-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 436}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2012-09-12', 'studyFirstSubmitQcDate': '2012-09-20', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percent of tissue loss', 'timeFrame': '1 year', 'description': 'percent of biopsy tissue loss during pathologic processing. comparing the core length as recorded on the biopsy needle notch and on the histology slide'}], 'secondaryOutcomes': [{'measure': 'prostate cancer detection rate', 'timeFrame': '1 year'}, {'measure': 'processing time', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '22498214', 'type': 'BACKGROUND', 'citation': 'Obek C, Doganca T, Erdal S, Erdogan S, Durak H. Core length in prostate biopsy: size matters. J Urol. 2012 Jun;187(6):2051-5. doi: 10.1016/j.juro.2012.01.075. Epub 2012 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of:\n\n1. Biopsy core length obtained (i.e. collecting all tissue fragments)\n2. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)\n3. Pathologist interpretability\n4. Processing time\n5. Prostate cancer detection.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 years or older\n* Planned for radical or open prostatectomy operation or Planned for TRUS prostate biopsy procedure.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Patient's unwilling to participate."}, 'identificationModule': {'nctId': 'NCT01692405', 'briefTitle': 'Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample', 'organization': {'class': 'INDUSTRY', 'fullName': 'UC Care, Ltd.'}, 'officialTitle': 'Semi-automatic Download of Prostate Biopsy Cores While Keeping the Orientation, Unfolding and Unity of the Sample', 'orgStudyIdInfo': {'id': '0086-12-EMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard method', 'description': 'Standard method- shaking the biopsy needle into a formalin container.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Download onto a biopsy sponge pad', 'description': 'Samples will be downloaded by moving the needle notch on a biopsy sponge pad.', 'interventionNames': ['Procedure: biopsy sponge pad']}, {'type': 'EXPERIMENTAL', 'label': 'Dowloading the biopsy cores using NavigoBx system', 'description': "Downloading the biopsy cores using NavigoBx™ system. The NaviGoBx™ device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.", 'interventionNames': ['Device: NaviGo Bx™']}], 'interventions': [{'name': 'NaviGo Bx™', 'type': 'DEVICE', 'description': 'The NaviGoBx™ system is a device and method that enables an accurate reporting of the exact longitudinal location and direction of the biopsy specimen along the needle notch as well as the accurate length of the specimen. Acquiring this information during the biopsy extraction session provides an accurate designation of the location of any later region of interest within the specimen itself to the longitudinal position along the needle mandrel.', 'armGroupLabels': ['Dowloading the biopsy cores using NavigoBx system']}, {'name': 'biopsy sponge pad', 'type': 'PROCEDURE', 'description': 'the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.', 'armGroupLabels': ['Download onto a biopsy sponge pad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18101', 'city': 'Afula', 'country': 'Israel', 'facility': 'Haemek madical center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UC Care, Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}