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

Olympus

Status: Completed

Conditions: Kidney Stone; Ureteral Stone

Treatments: Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04556201

2020-URO-01

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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450 participants in 1 patient group

Thulium Fiber Laser lithotripsy

Experimental group

Description:

Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL

Treatment:

Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System