Kidney Stone, Ureteral Stone
Conditions
Brief 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.
Interventions
DEVICESOLTIVE™ Premium SuperPulsed Laser Fiber System
SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only
Sponsors
Olympus Corporation of the Americas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. ≥18 years of age 2. Medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL 3. Willing and able to provide informed consent 4. Female and of childbearing age with a negative pregnancy test
Exclusion criteria
1. Contraindicated for uteroscopy, PCNL or mini PCNL as determined by the physician 2. Inability to tolerate anesthesia for any reason 3. Unable or unwilling to provide informed consent 4. Concurrently participating in another competing clinical study 5. Known ureteral stricture 6. Unwilling or unable to return for follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stone free rate | 3 month | Stone free rate as determined by standard of care imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total procedure time | During procedure | Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes |
| Accessory devices used | During procedure | Types of accessory devices used during the procedure (ureteroscopy, PCNL or mini-PCNL) and the total time used during the procedure in minutes |
| Total laser energy time | During procedure | Measured from first to last footswitch press in minutes |
| Device deficiencies | During procedure | Number of device deficiencies during the procedure |
| Rate of treatment/interventions needed | At 1 month follow-up and 3 month follow-up | Types of treatments and/or interventions needed post-procedure at the follow-up visits and the number of times treatments and/or interventions were performed |
| Adverse events | At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up | AEs related to device or procedure and non-serious AEs related to device or procedure |
Countries
Denmark, Portugal, United States
Outcome results
None listed