Ignite Creation Date:
2024-05-06 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03679819
Status:
UNKNOWN
Last Update Posted:
2019-09-26
First Post:
2018-09-17
Brief Title:
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound Exact Imaging Scanner ExactVu for the Detection of Prostate Cancer
Sponsor:
Institut Paoli-Calmettes
Organization:
Institut Paoli-Calmettes
Study Overview
Official Title:
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound Exact Imaging Scanner ExactVu for the Detection of Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2019-09
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:
EXACTVU
Brief Summary:
The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference
Detailed Description:
The primary objective of this study is to evaluate the performance of HR-TRUS in detection of prostate cancer lesions relative to whole mount section after radical prostatectomy as the reference The analysis will include the detection of all prostate cancer lesions as well as the detection of significant prostate cancer lesions With this approach it is possible to calculate the sensitivity specificity negative predictive value positive predictive value and overall accuracy of the correct detection of prostate cancer in the prostate These results are of importance when the ExactVu ultrasound scanner is to be used later for prostate cancer diagnosis using targeted biopsies
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-A01745-48 | OTHER | ANSM IDRCB | None |