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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.)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06982235). StuddyBuddy aggregates publicly available trial information.