Actively Recruiting
Stone and Laser Therapies Post-Market Study evaluating Boston Scientific devices in urinary tract procedures and BPH treatment
Led by Boston Scientific Corporation · Updated on 2026-05-12
238
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The SALT study focuses on collecting ongoing safety and performance information about Boston Scientific's medical devices used in urinary tract diagnostic and therapeutic procedures, including treatments for benign prostatic hyperplasia (BPH). This multi-center, open-label observational study monitors these devices after they are already available on the market to better understand their real-world use and effects. Participants include adults undergoing procedures involving these devices for urinary tract issues or BPH with related symptoms. The study involves two groups: one undergoing urinary tract procedures with the study devices, and the other receiving BPH treatment using the devices. The devices being evaluated include the LithoVue Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring and the Pulse 120H Holmium Laser System with MOSES 2.0 Technology. These devices are used during the diagnostic or therapeutic procedures or surgical treatment as applicable. Participants will be followed for one year after their procedure to track safety events and device performance. Researchers will monitor serious adverse events related to the devices from the procedure through 12 months afterward. They will also assess stone clearance rates 21 to 90 days post-procedure and changes in BPH symptoms at six months. Participants will attend follow-up visits to report outcomes and ensure ongoing monitoring of safety and device effectiveness in everyday use.
CONDITIONS
Brief Title
Stone and Laser Therapies Post-Market Study (SALT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For urinary tract procedure cohort: Subject plans to undergo diagnostic and/or therapeutic urinary tract procedure with Boston Scientific device(s)
- Subject is willing and able to complete all follow-up visits
- For BPH cohort: Subject is 40 years of age or older
- Subject has a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
- Subject plans to undergo BPH treatment with Boston Scientific device(s)
- Subject is willing and able to complete all follow-up visits
You will not qualify if you...
- For urinary tract procedure cohort: Subject requires simultaneous surgical treatment for BPH
- Subject is unwilling or unable to provide consent
- Any condition that prevents study participation, such as history of medical non-compliance
- For BPH cohort: Subject requires simultaneous upper urinary calculi lithotripsy procedure (except bladder calculi)
- Subject is unwilling or unable to provide consent
- Any condition that prevents study participation, such as history of medical non-compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of the procedure
Participants undergo diagnostic and/or therapeutic urinary tract procedures or BPH treatment using Boston Scientific study devices.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are followed for safety and device performance for up to 12 months after the procedure.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 5 locations
1
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
University of Miami Hospital
Miami, Florida, United States, 33442
Actively Recruiting
3
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
4
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
5
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
W
Winnie Chen
C
Curtis Blackwell
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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