Stopped: Study team paused enrollment
This clinical trial tests whether it is feasible to use the OmnEcoil system for transrectal magnetic resonance imaging (MRI) to visualize and biopsy suspicious lesions in the prostate. The OmnEcoil device combines an endorectal coil (a type of wire placed within the rectum during diagnostic endorectal MRI to take better images of the prostate) with an endorectal probe. The OmnEcoil system is designed to allow for MRI to be used at the same time to image the prostate and aid in the biopsy of the suspected prostate cancer. Usually, these are performed as two separate events at two separate times.
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Successful acquisition of tissue samples (early feasibility study)
Timeframe: Start of procedure to end of procedure, an average of less than 1 day
Physician device-user scores (early feasibility study)
Timeframe: Start of procedure to end of procedure, an average of less than 1 day
Incidence of biopsy-related grade >= 3 adverse events (early feasibility study)
Timeframe: Up to 30 days after end of procedure
Successful acquisition of diagnostic tissue samples (traditional feasibility study)
Timeframe: Start of procedure to end of procedure, an average of less than 1 day
Presence of cancer containing biopsies of dominant targets (traditional feasibility study)
Timeframe: Start of procedure to end of procedure, an average of less than 1 day
Incidence of biopsy-related grade >= 3 adverse events (traditional feasibility study)
Timeframe: Up to 30 days after end of procedure