Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser for Ureteroscopic Management of Kidney Stones

Study Overview
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Brief Summary
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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
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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.

Official Title
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Thulium Fiber Laser (TFL) Versus Holmium MOSES Laser in Ureteroscopic Management of Kidney Stones 10-20mm: A Randomized Prospective Clinical Trial

Conditions
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Kidney Stone

Intervention / Treatment
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* Device: Thulium Fibre Laser
* Device: MOSES Holmium Laser


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thulium Fibre Laser (TFL)<br>Patients randomized to this arm will undergo treatment using the TFL. | Device: Thulium Fibre Laser<br>* Participants will undergo treatment using the TFL<br>|
| Experimental: MOSES Holmium Laser<br>Patients randomized to this arm will undergo treatment using the MOSES Holmium laser. | Device: MOSES Holmium Laser<br>* Participants will undergo treatment using the MOSES Holmium laser.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Time | Measured in number of minutes from the insertion of the ureteroscope to the removal of the ureteroscope. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 and 12 weeks post-op | 
| Total operative time | Measured in n minutes from the anesthesia induction until placement of the stent. | Intraoperative | 
| Lasing time | Measured in minutes and defined as the time the laser was in use, not including pedal pauses. | Intraoperative | 
| Total energy used | Measured in kilojoules, defined as energy used to fragment the stones into small pieces (≤2 mm). | Intraoperative | 
| 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. | Intraoperative | 
| Number of times the laser pedals are pressed | Measured as a numerical value, defined as number of left, right, and total pedal presses | Intraoperative | 
| Percentage of Patients with Post-op Complications | Percentage of patients that results with a post-op complication | 4 weeks |