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

Completed · Not applicable

Conditions studied: Kidney Stone, Ureteral Stone

In brief

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.

Key facts

Study ID

NCT04556201

Run by

Olympus Corporation of the Americas

People needed

450

Starts

2020-12-01

Expected to finish

2023-05-30

Last updated by the study team

2023-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Mount Sinai West — New York, New York, United States
• Ohio State Wexner Medical Center — Columbus, Ohio, United States
• University Southern Denmark — Fredericia, Denmark
• Hospital CUF Descobertas — Lisbon, Portugal

Full record on ClinicalTrials.gov

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