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Recruiting
NCT06982235
Stone and Laser Therapies Post-Market Study (SALT)
Conditions: Benign Prostate Hypertrophy(BPH), Renal Calculi, Ureteral Stones, Kidney Stones, Calculi, Urinary, Urinary Tract Procedure
Sex: All
Healthy volunteers: No
Enrollment: 238
Sponsor: Boston Scientific Corporation
Location: Mayo Clinic Phoenix Phoenix Arizona
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 Criteria
Inclusion Criteria:
For urinary tract procedure cohort:
1. Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)
2. Subject is willing and able to complete all follow-up visits
For BPH cohort:
1. Subject is ≥ 40 years of age
2. Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
3. Subject intends to undergo BPH treatment with qualified BSC device(s)
4. Subject is willing and able to complete all follow-up visits
Exclusion Criteria:
For urinary tract procedure cohort:
1. Subject requires simultaneous surgical treatment for BPH
2. Unwilling or unable to provide consent
3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
For BPH cohort:
1. Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
2. Unwilling or unable to provide consent
3. Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
Source: ClinicalTrials.gov (NCT06982235). StuddyBuddy aggregates publicly available trial information.