Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:13 AM
Study NCT ID:
NCT05470127
Status:
RECRUITING
Last Update Posted:
2025-05-07
First Post:
2022-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011469', 'term': 'Prostatic Diseases'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The two biopsy needle sets will be used in the same patient during the procedure.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-02', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure Success', 'timeFrame': '1 Day of the procedure', 'description': 'Percentage of tissue samples collected that are suitable for pathological review'}, {'measure': 'Core length of tissue in the sample', 'timeFrame': '1 Day of the procedure', 'description': 'Quantity of Tissue Samples Collected'}, {'measure': 'weight of tissue in the sample', 'timeFrame': '1 Day of the procedure', 'description': 'Quantity of Tissue Samples Collected'}, {'measure': 'Tissue Sample Preparation', 'timeFrame': '1 Day of the procedure', 'description': 'Time required to prepare the tissue samples for pathological review'}], 'secondaryOutcomes': [{'measure': 'Ease of use of the biopsy needle', 'timeFrame': '1 Day of the procedure', 'description': 'Utility of the biopsy needle measured with a Likert scale of 1 to 5'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prostate CA', 'Needle biopsy'], 'conditions': ['Prostate Disease', 'Prostate CA']}, 'descriptionModule': {'briefSummary': 'Currently used biopsy devices do not predictably obtain full cores of tissue and the tissue obtained is often fragmented and disrupted making it difficult for pathological review. This post-market study will assess the utility of the SUREcore biopsy needle and the coreCARE specimen retrieval device versus a standard of care biopsy needle and the typical tissue container used in urology offices and clinics today.', 'detailedDescription': 'The safety and performance of the SUREcore and coreCARE devices will be compared to matched prostate tissue collected with a standard of care biopsy needle and tissue retrieval system. Following informed consent, prostate tissue biopsy samples will be obtained using the systematic 12 core biopsy template-- 6 with the typical biopsy needle and 6 with the SUREcore needle. Tissue samples will be randomized to retrieval with the swiping method or using the coreCARE device. Adverse events will be documented both during the procedure and within 5 days after the procedure. The user will be asked to rank the use of both biopsy tools during the procedure and a pathologist will be asked to assess the quality of the tissue cores obtained.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Prostate tissue is to be collected, which is only present in males.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male scheduled for prostate biopsy\n* Able to provide informed consent\n* Able and willing to provide verbal assessment of his condition 5 days post-procedure\n\nExclusion Criteria:\n\n* Unwilling to provide consent'}, 'identificationModule': {'nctId': 'NCT05470127', 'briefTitle': 'Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uro-1 Medical'}, 'officialTitle': 'Evaluation of the Performance of a Novel Prostate Biopsy System Compared With Standard of Care Biopsy Needle on Quantitative and Qualitative Tissue Parameters', 'orgStudyIdInfo': {'id': 'SUREcore v. SOC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SUREcore biopsy needle', 'description': 'The SUREcore needle will be used to collect up to 10 tissue samples', 'interventionNames': ['Device: Prostate biopsy needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care biopsy needle', 'description': 'The urologist will use his/her standard biopsy needle to collect up to 15 tissue samples', 'interventionNames': ['Device: Prostate biopsy needle']}], 'interventions': [{'name': 'Prostate biopsy needle', 'type': 'DEVICE', 'description': 'Prostate tissue biopsy with a biopsy needle', 'armGroupLabels': ['SUREcore biopsy needle', 'Standard of Care biopsy needle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30115', 'city': 'Cartersville', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeffrey Proctor, MD', 'role': 'CONTACT', 'email': 'jproctor@gaurology.com', 'phone': '7706071893'}, {'name': 'Jeffrey Proctor, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Georgia Urology', 'geoPoint': {'lat': 34.16533, 'lon': -84.80231}}], 'centralContacts': [{'name': 'Thomas Lawson, PhD', 'role': 'CONTACT', 'email': 'drthomlawson@gmail.com', 'phone': '5102061794'}, {'name': 'Jack Snoke', 'role': 'CONTACT', 'email': 'pjsnoke@uro1medical.com', 'phone': '3365750434'}], 'overallOfficials': [{'name': 'Thomas Lawson, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lawson & Associates'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Likert scale means for use of either of the biopsy needles will be available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uro-1 Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}