Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
NCT03679819 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2019-09-26
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.
Conditions
Interventions
- DEVICE
-
HR-TRUS
Medical procedures to be performed in the study consist of subject preparation and prostate imaging. The HR-TRUS exam will be done with a transrectal probe either the day before surgery, or in the OR right before surgery. The exam will be done in the same manner as during a regular transrectal ultrasound exam and no invasive procedures will be associated.
Sponsors & Collaborators
-
Exact Imaging
collaborator INDUSTRY -
Institut Paoli-Calmettes
lead OTHER
Principal Investigators
-
Jochen Walz, MD · Institut Paoli-Calmettes
Eligibility
- Min Age
- 35 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-05
- Primary Completion
- 2021-04-30
- Completion
- 2021-12-31
Countries
- France
Study Locations
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