Stone and Laser Therapies Post-Market Study
Boston Scientific Corporation
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.
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
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceUreteroscope system
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
- DeviceLaser system
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Locations (5)
- Mayo Clinic PhoenixPhoenix, Arizona
- University of Miami HospitalMiami, Florida
- University of South FloridaTampa, Florida
- Indiana University Medical CenterIndianapolis, Indiana
- Duke University Medical CenterDurham, North Carolina