Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05179720
Status:
UNKNOWN
Last Update Posted:
2022-10-18
First Post:
2021-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': "Randomly assign patient groups according to the random number method.The biopsy sample inspector does not know the patient's biopsy method"}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-16', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positive rate of biopsy', 'timeFrame': '1 year', 'description': 'Including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer'}], 'secondaryOutcomes': [{'measure': 'Biopsy complications include (infection, bleeding, etc.)', 'timeFrame': '1 year', 'description': 'Biopsy complications include (infection, bleeding, etc.)'}, {'measure': 'Pain score of biopsy patients (NRS score)', 'timeFrame': '1 year', 'description': 'Pain score of biopsy patients (NRS score)'}, {'measure': 'Biopsy time', 'timeFrame': '1 year', 'description': 'Biopsy time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy', 'detailedDescription': 'This study is a multi-center prospective study. Patients who meet the indications for prostate biopsy were included in this study.The study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. Exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. The main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.Secondary results include: (1)Biopsy complications include (infection, bleeding, etc.).(2)Pain score of biopsy patients (NRS score).(3) Biopsy time'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSuspected prostate cancer patients Can tolerate prostate puncture\n\nExclusion Criteria:\n\nSymptomatic acute or chronic inflammation of the prostate Patients with other cancers'}, 'identificationModule': {'nctId': 'NCT05179720', 'briefTitle': 'The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy', 'orgStudyIdInfo': {'id': 'CSZ02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'puncture stent-assisted transperineal prostate biopsy', 'description': 'This group of patients underwent puncture stent-assisted transperineal prostate biopsy.', 'interventionNames': ['Other: puncture stent-assisted transperineal prostate biopsy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'transperineal free-hand biopsy', 'description': 'This group of patients underwent perineal free-hand biopsy', 'interventionNames': ['Other: puncture stent-assisted transperineal prostate biopsy']}], 'interventions': [{'name': 'puncture stent-assisted transperineal prostate biopsy', 'type': 'OTHER', 'description': 'Patients in the experimental group used a puncture stent to assist transperineal prostate biopsy', 'armGroupLabels': ['puncture stent-assisted transperineal prostate biopsy', 'transperineal free-hand biopsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '276600', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'shouzhen chen', 'role': 'CONTACT', 'email': 'Jiangxin98@mail.sdu.edu.cn', 'phone': '18560089085'}], 'facility': 'Qilu hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Shouzhen Chen, Dr.', 'role': 'CONTACT', 'email': 'chensz@mail.sdu.edu.cn', 'phone': '18560089085'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}