Stone and Laser Therapies Post-Market Study (SALT)
Purpose
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.
Conditions
- Benign Prostate Hypertrophy(BPH)
- Renal Calculi
- Ureteral Stones, Kidney Stones
- Calculi, Urinary
- Urinary Tract Procedure
Eligibility
- Eligible Ages
- All ages
- Eligible Sex
- All
- Accepts 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.)
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Urinary Tract Procedure Cohort | Subjects intend to undergo diagnostic and/or therapeutic urinary tract procedure with study device(s) |
|
| 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) |
|
Recruiting Locations
Miami 4164138, Florida 4155751 33442
Indianapolis 4259418, Indiana 4921868 46202
More Details
- NCT ID
- NCT06982235
- Status
- Recruiting
- Sponsor
- Boston Scientific Corporation
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.