Clinical Trials

Inclusion Criteria:

For Lithotripsy cohort:

• Subject is undergoing treatment for urinary calculi. 
• Subject is willing and able to return for all follow-up visits.

For BPH cohort:

• Subject is ≥ 40 years of age 2.
• Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms.
• IPSS (International Prostate Symptom Score) ≥ 12.
• Qmax (Peak Flow Rate) ≤ 15 mL/s.
• Subject is willing and able to return for all follow-up visits.

Exclusion Criteria:

For Lithotripsy cohort:

• Subject has uncontrolled bleeding disorders and coagulopathy.
• Subject has untreated urinary tract infection (UTI).
• Subject requires simultaneous HoLEP procedure.

For BPH cohort:

• Subject has a diagnosis of bladder cancer.
• Subject has a diagnosis of prostate cancer.
• Subject with prostate-specific antigen (PSA) ˃ 10 ng/mL suggestive of prostate cancer is not eligible unless patient has concomitant negative prostate biopsy.
• Subject has acute prostatitis, a prostate abscess, or neurogenic bladder.
• Subject has urethral stricture disorder.
• Subject has uncontrolled bleeding disorders and coagulopathy.
• Subject has untreated urinary tract infection (UTI).
• Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi).

Eligibility last updated 12/16/21.  Questions regarding updates should be directed to the study team contact.