Trials / Completed
CompletedNCT04556201
The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones
A Prospective, Multicenter, Post-Market Clinical Registry to Collect Real-World Evidence on the Clinical Performance of the SOLTIVE™ Laser for Treatment of Kidney or Ureteral Stones
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450 (actual)
- Sponsor
- Olympus Corporation of the Americas · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to collect real-world evidence on the performance of the SOLTIVE™ Premium SuperPulsed Laser System for laser lithotripsy in ureteroscopy, percutaneous nephrolithotomy (PCNL) and mini PCNL for kidney and ureteral stones.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SOLTIVE™ Premium SuperPulsed Laser Fiber System | SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only |
Timeline
- Start date
- 2020-12-01
- Primary completion
- 2023-02-02
- Completion
- 2023-05-30
- First posted
- 2020-09-21
- Last updated
- 2023-11-01
Locations
7 sites across 3 countries: United States, Denmark, Portugal
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04556201. Inclusion in this directory is not an endorsement.