ClariCore System Used in Transperineal Prostate Biopsy

Exclusion Criteria

• •1. Any anatomical or co-morbidity contraindications to transperineal prostate biopsy or transperineal prostate mapping biopsy
• •2. Acute painful perianal disorder (i.e. rectal abscess)
• •3. Symptomatic, acute prostatitis
• •4. Surgical absence of a rectum or the presence of a rectal fistula
• •5. Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
• •6. Previous prostate intervention \[TURP (bipolar, monopolar, laser)\] TUMT, HIFU, Cryo, Rezum, Urolift\], not including previous prostate biopsy
• •7. Current required use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) prior to a medical procedure; or history of a bleeding disorder (e.g. coagulopathy)
• •8. Prior pelvic irradiation
• •9. Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)
• •10. Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
• •11. Patient has compromised immune system, in the opinion of the Investigator
• •12. Active inflammatory bowel disease within the last 6 months
• •13. Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g.
• •significant cardiovascular conditions or allergies)
• •14. Patient is not likely to comply with the protocol or follow up evaluation
• •15. Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study