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

Not Applicable

Completed

• Conditions: Kidney Stone; Ureteral Stone
• Interventions: Device: SOLTIVE™ Premium SuperPulsed Laser Fiber System

• Registration Number: NCT04556201
• Lead Sponsor: Olympus Corporation of the Americas

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-07
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-21
• Study Start: 2020-12-01
• Primary Completion: 2023-02-02
• Study Completion: 2023-05-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-31
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thulium Fiber Laser lithotripsy	SOLTIVE™ Premium SuperPulsed Laser Fiber System	Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL

Primary Outcome Measures

Name	Time	Method
Stone free rate	3 month	Stone free rate as determined by standard of care imaging

Secondary Outcome Measures

Name	Time	Method
Total laser energy time	During procedure	Measured from first to last footswitch press in minutes
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
Device deficiencies	During procedure	Number of device deficiencies during the procedure
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
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

Trial Locations

Locations (7)

Hospital CUF Descobertas; 🇵🇹 Lisboa, Portugal

University Southern Denmark; 🇩🇰 Fredericia, Denmark

Mount Sinai West; 🇺🇸 New York, New York, United States

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

Ohio State Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States