Stone and Laser Therapies Post-Market Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 238
- Locations
- 5
- Primary Endpoint
- Occurrence of Serious Adverse Events related to BSC study devices
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For urinary tract procedure cohort:
- •Subject intends to undergo diagnostic and/or therapeutic urinary tract procedure with qualified BSC device(s)
- •Subject is willing and able to complete all follow-up visits
- •For BPH cohort:
- •Subject is ≥ 40 years of age
- •Subject with a diagnosis of benign prostatic hyperplasia (BPH) with lower urinary tract symptoms
- •Subject intends to undergo BPH treatment with qualified BSC device(s)
- •Subject is willing and able to complete all follow-up visits
Exclusion Criteria
- •For urinary tract procedure cohort:
- •Subject requires simultaneous surgical treatment for BPH
- •Unwilling or unable to provide consent
- •Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
- •For BPH cohort:
- •Subject requires simultaneous upper urinary calculi lithotripsy procedure (not applicable to bladder calculi)
- •Unwilling or unable to provide consent
- •Any other condition which, in the opinion of the investigator, precludes study participation (e.g., history of medical non-compliance, etc.)
Arms & Interventions
Urinary Tract Procedure Cohort
Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)
Intervention: Laser system (Device)
Urinary Tract Procedure Cohort
Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s)
Intervention: Ureteroscope system (Device)
Benign Prostatic Hyperplasia Cohort
Subjects are at least 40 years of age diagnosed with BPH with lower urinary tract symptoms and intend to undergo BPH treatment with study device(s)
Intervention: Laser system (Device)
Outcomes
Primary Outcomes
Occurrence of Serious Adverse Events related to BSC study devices
Time Frame: From procedure to 12-months after the procedure
The primary endpoint is the occurrence of serious adverse events related to BSC study devices.
Secondary Outcomes
- Assess Stone Free Rate in therapeutic Urinary Tract Procedures(21 - 90 days after the procedure)
- Change in BPH symptoms(6 months after the procedure)