The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Kidney Stone, Ureteral Stone

Intervention / Treatment
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* Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years of age Medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL Willing and able to provide informed consent Female and of childbearing age with a negative pregnancy test Exclusion Criteria: Contraindicated for uteroscopy, PCNL or mini PCNL as determined by the physician Inability to tolerate anesthesia for any reason Unable or unwilling to provide informed consent Concurrently participating in another competing clinical study Known ureteral stricture Unwilling or unable to return for follow-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thulium Fiber Laser lithotripsy<br>Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL | Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System<br>* SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Stone free rate as determined by standard of care imaging | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total laser energy time | Measured from first to last footswitch press in minutes | During procedure | 
| Total procedure time | Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes | During procedure | 
| Accessory devices used | Types of accessory devices used during the procedure (ureteroscopy, PCNL or mini-PCNL) and the total time used during the procedure in minutes | During procedure | 
| Adverse events | AEs related to device or procedure and non-serious AEs related to device or procedure | At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up | 
| Device deficiencies | Number of device deficiencies during the procedure | During procedure | 
| Rate of treatment/interventions needed | 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 | At 1 month follow-up and 3 month follow-up |