ProstaMetric Clinical Study
Research type
Research Study
Full title
A MULTI-CENTER STUDY TO DEMONSTRATE THE EQUIVALENCE OF PROSTATE VOLUME MEASURED BY THE PROSTAMETRIC SYSTEM VERSUS TRANS-RECTAL ULTRASOUND (TRUS) AND/OR MAGNETIC RESONANCE IMAGING (MRI) IN AN INTENDED USE POPULATION OF SUBJECTS SCHEDULED FOR TRUS/MRI
IRAS ID
209849
Contact name
Christopher LaFarge
Contact email
Sponsor organisation
MedicaMetrix
Duration of Study in the UK
0 years, 2 months, 30 days
Research summary
A digital rectal examination (DRE) of the prostate is a common minimally invasive procedure for determining physical characteristics of the prostate. It is used in combination with several other variables to determine the optimal pathway for patients to follow in addressing the status of their disease. One of the more important variables is considered to be the volume of the prostate. The primary clinical issue is that prostate volume cannot be measured without first doing a costly and more invasive imaging procedure. The ProstaMetric System enables a quantitative determination of prostate volume based on measurement of the palpable surface of the prostate as part of the initial standard DRE examination at a low cost.
The objective of this study is to demonstrate the correlation between prostate volume measured by the ProstaMetric System and volume measured by TRUS and/or MRI in subjects in the intended use population.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0568
Date of REC Opinion
10 Aug 2016
REC opinion
Further Information Favourable Opinion