Stone and Laser Therapies Post-Market Study (SALT)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBoston Scientific Corporation

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

Treatment groups

238 Participants
are divided into 2 treatment groups

Sponsors and collaborators