Study that compares Prostate Volume Measured by the ProstaMetrix System with Ultrasound.
Not Applicable
- Conditions
- Health Condition 1: R398- Other symptoms and signs involvingthe genitourinary system
- Registration Number
- CTRI/2021/09/036602
- Lead Sponsor
- MedicaMetrix Devices Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Male age between 45 and 85 scheduled for TRUS and DRE as part of his clinical work-up for prostate disease
Exclusion Criteria
Inability to perform the rectal examination
Lower Urinary Tract congenital abnormalities
Inability to understand or refusal to grant Informed Consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percent difference beween Transrectal Ultrasound and ProstaMetrix Volume measurements will be characterized with 95 percent confidence intervalsTimepoint: Real-time
- Secondary Outcome Measures
Name Time Method Improve screening and diagnosis using PSA Density. Improve the quality of follow up for patients being treated for Prostate cancerTimepoint: 6 months