Trials / Recruiting
RecruitingNCT06982235
Stone and Laser Therapies Post-Market Study (SALT)
Stone and Laser Therapies Post-Market Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 238 (estimated)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
- Benign Prostate Hypertrophy(BPH)
- Renal Calculi
- Ureteral Stones, Kidney Stones
- Calculi, Urinary
- Urinary Tract Procedure
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ureteroscope system | LithoVue™ Elite Single-Use Digital Flexible Ureteroscope System with intrarenal pressure monitoring |
| DEVICE | Laser system | Pulse™ 120H Holmium Laser System with MOSES™ 2.0 Technology |
Timeline
- Start date
- 2025-06-30
- Primary completion
- 2029-02-01
- Completion
- 2029-02-01
- First posted
- 2025-05-21
- Last updated
- 2026-04-15
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06982235. Inclusion in this directory is not an endorsement.