Ureteroscope system: LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring
Laser system: Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology
Study 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
Sex
ALL
Min age
—
Max age
—
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 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.)
Primary outcome measure(s)
Occurrence of Serious Adverse Events related to BSC study devices — From procedure to 12-months after the procedure The primary endpoint is the occurrence of serious adverse events related to BSC study devices.
Trial sites (5)
Facility
City
Region
Status
Mayo Clinic Phoenix
Phoenix
Arizona
University of Miami Hospital
Miami
Florida
University of South Florida
Tampa
Florida
Indiana University Medical Center
Indianapolis
Indiana
Duke University Medical Center
Durham
North Carolina
More Boston Scientific Corporation trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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