Status:
RECRUITING
Stone and Laser Therapies Post-Market Study (SALT)
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Benign Prostate Hypertrophy(BPH)
Renal Calculi
Eligibility:
All Genders
Brief 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 trac...
Detailed Description
The SALT study is a multi-center, open label, non-randomized, prospective observational study to document on-going post-market safety and device performance data of BSC commercially available study de...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2029
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT06982235
Start Date
June 30 2025
End Date
February 1 2029
Last Update
December 23 2025
Active Locations (4)
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1
University of Miami Hospital
Miami, Florida, United States, 33442
2
University of South Florida
Tampa, Florida, United States, 33606
3
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
4
Duke University Medical Center
Durham, North Carolina, United States, 27710