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NCT06982235Recruiting

Stone and Laser Therapies Post-Market Study (SALT)

Boston Scientific Corporation

Start Date

6/30/2025

Completion Date

2/1/2029

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.

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 devices that are used in diagnostic and/or therapeutic urinary tract procedures or surgical treatment for BPH. Enrolled subjects undergoing diagnostic or therapeutic procedures using study devices will be followed for 1 year after the index procedure is complete.

Eligibility Criteria

Age Range: No minimum to No maximum

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.)

Interventions

DEVICE

Ureteroscope system

DEVICE

Laser system

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Conditions

Benign Prostate Hypertrophy(BPH)Renal CalculiUreteral Stones, Kidney StonesCalculi, UrinaryUrinary Tract Procedure

Locations

Mayo Clinic Phoenix

Phoenix, Arizona 85054

United States

University of Miami Hospital

Miami, Florida 33442

United States

University of South Florida

Tampa, Florida 33606

United States

Indiana University Medical Center

Indianapolis, Indiana 46202

United States

Duke University Medical Center

Durham, North Carolina 27710

United States