Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser for Ureteroscopic Management of Kidney Stones
Primary Purpose
Kidney Stone
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Thulium Fibre Laser
MOSES Holmium Laser
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and over at the time of enrollment.
- Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
- Written informed consent to participate in the study
- Ability to comply with the requirements of the study procedures
Exclusion Criteria:
- Patients with ipsilateral distal ureteral stones or stricture.
- Stone size > 20 mm or multiple kidney stones in different calyces.
- Previous shock wave lithotripsy (SWL) treatment for the same stone.
- Participants with active urinary tract infection until appropriately treated
- Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
- Pregnancy.
- Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
- Participants who are uncooperative or cannot follow instructions.
- Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent.
- Patients with solitary kidney.
Sites / Locations
- Thunder Bay Regional Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Thulium Fibre Laser (TFL)
MOSES Holmium Laser
Arm Description
Patients randomized to this arm will undergo treatment using the TFL.
Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.
Outcomes
Primary Outcome Measures
Procedural Time
Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.
Secondary Outcome Measures
Stone Free Rate (SFR)
SRF will be defined as the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the urinary tract which were defined as ˂4 mm, asymptomatic, non-obstructive and non-infectious stone particles.
Total operative time
Measured in n minutes from the anesthesia induction until placement of the stent.
Lasing time
Measured in minutes and defined as the time the laser was in use, not including pedal pauses.
Total energy used
Measured in kilojoules, defined as energy used to fragment the stones into small pieces (≤2 mm).
Laser efficiency
Measured as mm per minute and defined as the stone size (mm) that can be treated every minute; the cumulative stone size (adding the maximum size of each stone that is treated during the surgery) is divided by the lasering time.
Number of times the laser pedals are pressed
Measured as a numerical value, defined as number of left, right, and total pedal presses
Percentage of Patients with Post-op Complications
Percentage of patients that results with a post-op complication
Full Information
NCT ID
NCT05598645
First Posted
October 25, 2022
Last Updated
November 28, 2022
Sponsor
Thunder Bay Regional Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05598645
Brief Title
Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser for Ureteroscopic Management of Kidney Stones
Official Title
Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser in Ureteroscopic Management of Kidney Stones 10-20mm: A Randomized Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thunder Bay Regional Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare the efficacy and safety of both types of lasers, Holmium MOSES and TFL, in management of kidney stones requiring treatment.
Detailed Description
The prevalence of kidney stones has been increasing over the last two decades with lifetime recurrence risk reported to be as high as 50%. Holmium lasers are nowadays considered the "gold standard" for treatment of urinary tract stones.
Recently, the holmium laser urology platform from Lumenis has been updated to include a new technology called MOSES, which provides improved energy delivery of the laser to treat the stones, reduces migration of the stone during the procedure, and limits potential collateral tissue damage.
A new generation of lasers has evolved due to the advances in laser fiber technology, leading to the development of the Thulium Fiber Laser (TFL). TFL can operate within a large range of energy, frequency and pulse duration settings. The small fiber size is one of the main advantages of TFL, as it allows better endoscope performance through easier deflection and bigger working channel space. Furthermore, it produces small stone fragments and better dusting capabilities compared to the standard Holmium laser when adjusted on the same power settings.
This study will compare the efficacy and safety of Holmium MOSES and TFL in management of kidney stones requiring treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thulium Fibre Laser (TFL)
Arm Type
Experimental
Arm Description
Patients randomized to this arm will undergo treatment using the TFL.
Arm Title
MOSES Holmium Laser
Arm Type
Experimental
Arm Description
Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.
Intervention Type
Device
Intervention Name(s)
Thulium Fibre Laser
Intervention Description
Participants will undergo treatment using the TFL
Intervention Type
Device
Intervention Name(s)
MOSES Holmium Laser
Intervention Description
Participants will undergo treatment using the MOSES Holmium laser.
Primary Outcome Measure Information:
Title
Procedural Time
Description
Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Stone Free Rate (SFR)
Description
SRF will be defined as the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the urinary tract which were defined as ˂4 mm, asymptomatic, non-obstructive and non-infectious stone particles.
Time Frame
4 and 12 weeks post-op
Title
Total operative time
Description
Measured in n minutes from the anesthesia induction until placement of the stent.
Time Frame
Intraoperative
Title
Lasing time
Description
Measured in minutes and defined as the time the laser was in use, not including pedal pauses.
Time Frame
Intraoperative
Title
Total energy used
Description
Measured in kilojoules, defined as energy used to fragment the stones into small pieces (≤2 mm).
Time Frame
Intraoperative
Title
Laser efficiency
Description
Measured as mm per minute and defined as the stone size (mm) that can be treated every minute; the cumulative stone size (adding the maximum size of each stone that is treated during the surgery) is divided by the lasering time.
Time Frame
Intraoperative
Title
Number of times the laser pedals are pressed
Description
Measured as a numerical value, defined as number of left, right, and total pedal presses
Time Frame
Intraoperative
Title
Percentage of Patients with Post-op Complications
Description
Percentage of patients that results with a post-op complication
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age and over at the time of enrollment.
Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx.
Written informed consent to participate in the study
Ability to comply with the requirements of the study procedures
Exclusion Criteria:
Patients with ipsilateral distal ureteral stones or stricture.
Stone size > 20 mm or multiple kidney stones in different calyces.
Previous shock wave lithotripsy (SWL) treatment for the same stone.
Participants with active urinary tract infection until appropriately treated
Uncorrected coagulopathy (anticoagulants or blood thinners which cannot be withheld before surgery).
Pregnancy.
Participants with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study.
Participants who are uncooperative or cannot follow instructions.
Participants who lack the capacity, or cannot speak English, in order to provide free and informed written consent.
Patients with solitary kidney.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shalyn Littlefield, MSc
Phone
(807) 684-6000
Email
shalyn.littlefield@tbh.net
First Name & Middle Initial & Last Name or Official Title & Degree
Hazem Elmansy, MD
Phone
(807) 684-6000
Email
elmansyh@tbh.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem Elmansy, MD
Organizational Affiliation
Urologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thunder Bay Regional Health Sciences Centre
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shalyn Littlefield, MSc
Email
shalyn.littlefield@tbh.net
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser for Ureteroscopic Management of Kidney Stones
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