Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-06 @ 5:12 PM
Study NCT ID:
NCT06550960
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of SureCore Plus Biopsy System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-arm study of study biopsy needle and standard of care biopsy needle'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-08', 'studyFirstSubmitDate': '2024-07-30', 'studyFirstSubmitQcDate': '2024-08-08', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedure success', 'timeFrame': 'During the procedure', 'description': '\\> 3 mm/cc of tissue collected in each biopsy'}, {'measure': 'Quality of biopsy tissue', 'timeFrame': 'During the procedure', 'description': 'Ranking by pathologist on scale of 0=unable to read to 5=all tissue complete for reading. The higher scores mean a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Performance of the study device', 'timeFrame': 'During the procedure', 'description': 'Ranking by MD using scale of 1=difficult to use to 5=outperformed SOC needles. The higher scores equate to better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['BPH']}, 'descriptionModule': {'briefSummary': 'This is a post-market study of a cleared biopsy system. The quality of tissue cores varies with standard of care biopsy needles. The SureCore Plus biopsy system is being evaluated as to quality and volume of tissue from prostate biopsy as compared to standard of care biopsy needles.', 'detailedDescription': 'Biopsy sampling of the prostate using TRUS or TPPB guidance is the current SoC approach for diagnosis of prostate cancer (CaP). Over the past decades the number of samples required and considered adequate has risen from 6 to 12-18 and sometimes as many as 30. Many practices routinely sample up to 20 cores of tissue. The SureCore Plus biopsy system is being to sample, obtain and retrieve prostate biopsy specimens in men undergoing scheduled diagnostic prostate biopsy and compare it with an standard of care (SoC) biopsy instrument and SoC method of specimen retrieval.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This is biopsy of the prostate. Only males have a prostate.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has BPH requiring a prostate biopsy\n* Able and willing to provide consent\n\nExclusion Criteria:\n\n* Active infection\n* Subject participating in an other device study of the prostate'}, 'identificationModule': {'nctId': 'NCT06550960', 'briefTitle': 'Evaluation of SureCore Plus Biopsy System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Uro-1 Medical'}, 'officialTitle': 'Evaluation of a Soft Tissue Biopsy System for Trans-rectal and Trans-perineal Biopsy of the Prostate Using Standard of Care and Artificial Intelligence (AI) Analysis', 'orgStudyIdInfo': {'id': '23-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SureCore Plus biopsy needle', 'description': 'Prostate biopsy of subject with BPH with a SureCore biopsy needle', 'interventionNames': ['Device: Evaluation of two biopsy systems']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care biopsy needle', 'description': 'Prostate biopsy of subject with BPH with a standard of care (SOC) biopsy needle', 'interventionNames': ['Device: Evaluation of two biopsy systems']}], 'interventions': [{'name': 'Evaluation of two biopsy systems', 'type': 'DEVICE', 'description': 'Each subject will have prostate biopsy taken in 6 locations in one lobe of the prostate and then biopsy in 6 locations in the other lobe of the prostate', 'armGroupLabels': ['Standard of Care biopsy needle', 'SureCore Plus biopsy needle']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jeffrey Proctor, MD', 'role': 'CONTACT', 'email': 'jproctor@georgiaurology.com', 'phone': '770 607 1893'}], 'overallOfficials': [{'name': 'Jeffrey Proctor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgia Urology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uro-1 Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}