The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones
Primary Purpose
Kidney Stone, Ureteral Stone
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SOLTIVE™ Premium SuperPulsed Laser Fiber System
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone
Eligibility Criteria
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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
Sites / Locations
- Mayo Clinic Arizona
- Loma Linda University Medical Center
- Kansas University Medical Center
- Mount Sinai West
- Ohio State Wexner Medical Center
- University Southern Denmark
- Hospital CUF Descobertas
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thulium Fiber Laser lithotripsy
Arm Description
Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
Outcomes
Primary Outcome Measures
Stone free rate
Stone free rate as determined by standard of care imaging
Secondary Outcome Measures
Total laser energy time
Measured from first to last footswitch press in minutes
Total procedure time
Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes
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
Adverse events
AEs related to device or procedure and non-serious AEs related to device or procedure
Device deficiencies
Number of device deficiencies during the 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
Full Information
NCT ID
NCT04556201
First Posted
September 7, 2020
Last Updated
February 8, 2023
Sponsor
Olympus Corporation of the Americas
1. Study Identification
Unique Protocol Identification Number
NCT04556201
Brief Title
The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
May 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olympus Corporation of the Americas
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Ureteral Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thulium Fiber Laser lithotripsy
Arm Type
Experimental
Arm Description
Subjects who have a medical indication for ureteroscopy, percutaneous nephrolithotomy (PCNL) or mini PCNL
Intervention Type
Device
Intervention Name(s)
SOLTIVE™ Premium SuperPulsed Laser Fiber System
Intervention Description
SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only
Primary Outcome Measure Information:
Title
Stone free rate
Description
Stone free rate as determined by standard of care imaging
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Total laser energy time
Description
Measured from first to last footswitch press in minutes
Time Frame
During procedure
Title
Total procedure time
Description
Measured from time of initial ureteroscope insertion to time of ureteroscope withdrawal in minutes
Time Frame
During procedure
Title
Accessory devices used
Description
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
Title
Adverse events
Description
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
Title
Device deficiencies
Description
Number of device deficiencies during the procedure
Time Frame
During procedure
Title
Rate of treatment/interventions needed
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Chew, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olivier Traxer, MD
Organizational Affiliation
Tenon Hospital, Sorbonne University, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Kansas University Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Mount Sinai West
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Ohio State Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
University Southern Denmark
City
Fredericia
ZIP/Postal Code
7000
Country
Denmark
Facility Name
Hospital CUF Descobertas
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Subject data collected during the study after de-identification.
IPD Sharing Time Frame
Immediately following publication
Citations:
PubMed Identifier
28213860
Citation
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Results Reference
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Citation
Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.
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C. Türk, A. Skolarikos, A. Neisius, A. Petrik, C. Seitz, K. Thomas, EAU Guidelines. European Association of Urology (EAU). 2019.
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Citation
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The Performance of the SOLTIVE Laser System for Laser Lithotripsy in Kidney or Ureteral Stones
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