About this trial
The objective of the SALT Study is to obtain post-market safety and device performance data for Boston Scientific's Stone and BPH study devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g., transurethral or percutaneous access routes) or benign prostatic hyperplasia (BPH) treatment.
Eligibility criteria
Qualifiers
Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)
Subject is willing and able to complete all follow-up visits
Subject is ≥ 40 years of age
Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
Disqualifiers
Subject requires simultaneous surgical treatment for BPH
Unwilling or unable to provide consent
Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
Trial design
Treatments tested in this trial
- Ureteroscope system
- Laser system