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

October 31, 2023 updated by: Olympus Corporation of the Americas

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Fredericia, Denmark, 7000
        • University Southern Denmark
  • Portugal
      • Lisboa, Portugal, 1998-018
        • Hospital Cuf Descobertas
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai West
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Ohio State Wexner Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone free rate
Time Frame: 3 month
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
Time Frame: During procedure
Measured from first to last footswitch press in minutes
During procedure
Total procedure time
Time Frame: During procedure
Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes
During procedure
Accessory devices used
Time Frame: 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
During procedure
Adverse events
Time Frame: 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
At procedure, immediate post-procedure, 1 month follow-up and 3 month follow-up
Device deficiencies
Time Frame: During procedure
Number of device deficiencies during the procedure
During procedure
Rate of treatment/interventions needed
Time Frame: 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
At 1 month follow-up and 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olympus Corporation of the Americas

Investigators

  • Principal Investigator: Ben Chew, MD, University of British Columbia
  • Principal Investigator: Olivier Traxer, MD, Tenon Hospital, Sorbonne University, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

February 2, 2023

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

September 7, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 31, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-URO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Subject data collected during the study after de-identification.

IPD Sharing Time Frame

Immediately following publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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