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:
Qilu Hospital of Shandong University
Organization:
Study Overview
Official Title:
The Application Research of Ultrasound Guided Puncture Stent Assisted Transperineal Prostate Biopsy
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: