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.
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.
Study Type
OBSERVATIONAL
Enrollment
238
LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
University of Miami Hospital
Miami, Florida, United States
RECRUITINGUniversity of South Florida
Tampa, Florida, United States
RECRUITINGIndiana University Medical Center
Indianapolis, Indiana, United States
RECRUITINGOccurrence of Serious Adverse Events related to BSC study devices
The primary endpoint is the occurrence of serious adverse events related to BSC study devices.
Time frame: From procedure to 12-months after the procedure
Assess Stone Free Rate in therapeutic Urinary Tract Procedures
For upper urinary tract stone procedures: Stone clearance assessed by stone free rate (SFR) at the post procedure imaging study.
Time frame: 21 - 90 days after the procedure
Change in BPH symptoms
In subjects with applicable benign prostatic hyperplasia (BPH) procedure(s): Improvement in BPH symptoms from baseline as measured by favorable change (decrease) in International Prostate Symptom Score (IPSS) at 6 months follow up, on a scale of 0 to 35.
Time frame: 6 months after the procedure
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Duke University Medical Center
Durham, North Carolina, United States
RECRUITING