Stone and Laser Therapies Post-Market Study (SALT)
Stone and Laser Therapies Post-Market Study
Boston Scientific Corporation
238 participants
Jun 30, 2025
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria8
- For urinary tract procedure cohort:
- 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
- For BPH cohort:
- Subject is ≥ 40 years of age
- Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
- Subject intends to undergo BPH treatment with qualified BSC device(s)
- Subject is willing and able to complete all follow-up visits
Exclusion Criteria8
- For urinary tract procedure cohort:
- 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.)
- For BPH cohort:
- Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
- 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.)
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Interventions
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06982235