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

Olympus Corporation of the Americas450 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

450

Conditions

Kidney Stone Ureteral Stone

Interventions

SOLTIVE™ Premium SuperPulsed Laser Fiber SystemDEVICE

SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

Stone free rate

Stone free rate as determined by standard of care imaging

Time frame: 3 month

Secondary Outcomes

Total laser energy time

Measured from first to last footswitch press in minutes

Time frame: During procedure

Total procedure time

Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes

Time frame: 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

Time frame: During procedure

Adverse events

AEs related to device or procedure and non-serious AEs related to device or procedure

Time frame: At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up

Device deficiencies

Number of device deficiencies during the procedure

Time frame: 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

Time frame: At 1 month follow-up and 3 month follow-up

Data from ClinicalTrials.gov

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