ProDevice Medical Supplies and Equipment LLC — Department of Health and Human Services STTR Phase I: Project Abstract Active surveillance (AS) is becoming more accepted as a reasonable treatm

Description

Project Abstract Active surveillance (AS) is becoming more accepted as a reasonable treatment option for men with low-risk prostate cancer (i.e. Gleason score 6, clinical stage T2a, PSA lt 10). Many AS protocols at major institutions call for a prostate saturation biopsy after initial diagnosis to confirm that the patient has no areas of higher-risk prostate cancer. For most patients who underwent prostate biopsy recognize it as a painful and lengthy procedure with an uncertain diagnosis due to limited accuracy. The biopsy needle devices for prostate biopsy in clinic are not optimal. To more completely sample all regions of the prostate prior to initiating AS, a transperineal approach prostate core biopsy is commonly performed. This research integrates fiveinnovative techniques, all proven feasible individually, to a High-yield and Accurate template-guided Transperineal saturation Biopsy (HATB) system. An end-cut biopsy needle tip with high inclination angle cutting edge, the high and instant suction vacuum