Thulium vs. Hol:YAG Laser

Study Overview
=================
Brief Summary
-----------------
This is a randomized prospective study to compare stone free rates and operative efficiency of two laser systems used during retrograde intrarenal surgery for kidney stone disease: A superpulsed thulium fiber laser (thulium) A pulse modulated high power holmium laser (Holmium)

Detailed Description
-----------------
This is a randomized prospective study. The purpose is to compare the stone free rate and operative efficiency of two leading contemporary laser systems used during retrograde intrarenal surgery for kidney stone disease. The researchers will compare the following two systems: A superpulsed thulium fiber laser (thulium) A pulse modulated high power holmium laser (Holmium) The researchers will recruit 82 subjects undergoing single stage unilateral ureteroscopy for renal stones with a volume between >5mm to < 20 mm. Subjects will be randomized to undergo lithotripsy with either Ho:YAG or Thulium lasers. All subjects will undergo surgical interventions that abide by broadly accepted guidelines and standards of care. The primary outcome is stone free rate evaluated by postoperative CT scans done 6-12 weeks after surgery.

Official Title
-----------------
Superpulsed Thulium Fiber Laser VS. Pulse Modulated High Power Holmium:YAG Laser For Retrograde Intrarenal Surgery

Conditions
-----------------
Nephrolithiasis

Intervention / Treatment
-----------------
* Device: Thulium Fibre Laser
* Device: Holmium:Yttrium-Aluminum-Garnet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Undergoing single stage unilateral RIRS for total stone burden volume >5mm to < 20 mm Preoperative CT scan for baseline measurements Exclusion criteria: Anatomic variations: horseshoe kidney, pelvic kidney, ptotic kidney, urinary diversion or ureteral stricture Ureteral stent Uric acid component >50% on stone analysis Prior ureteroscopy within 6 weeks of current surgery Irreversible coagulopathy Urothelial tumor(s), direct extraction of the stone(s) without needing laser lithotripsy, and failure to reach the stone in the upper urinary tract with the ureteroscope.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thulium Fibre Laser (TFL)<br>Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Thulium fibre laser (TFL) | Device: Thulium Fibre Laser<br>* The TFL is a relatively new laser in the field of urology. First introduced on the market in 2017, it offers theoretically superior stone dusting qualities and smaller fiber sizes to allow for better irrigation.<br>* Other names: TFL;|
| Experimental: Holmium:Yttrium-Aluminum-Garnet (Ho:YAG)<br>Patients who are randomized to undergo ureteroscopic laser lithotripsy with the Holmium:Yttrium-Aluminum-Garnet (Ho:YAG) laser | Device: Holmium:Yttrium-Aluminum-Garnet<br>* The Ho:YAG is currently the most commonly used laser in the field of urology and for the better part of the last 3 decades has been considered the gold standard for laser lithotripsy.<br>* Other names: Ho:YAG;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with stone free status | Stone free status as determined by 6-12 week postoperative CT scan to assess laser efficacy | 6-12 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fragmentation speed | Fragmentation speed is calculated by dividing stone volume by lasing time (mm3/sec). This is a measure of how quickly the laser breaks down the kidney stones. | Intraoperatively (Day 1) | 
| Lasing activity | Lasing activity is calculated by dividing lasing time by lithotripsy operative time (%). This measures the percentage of time during surgery that the surgeon is actively using the laser to break down kidney stones. | Intraoperatively (Day 1) | 
| Energy utilization | Energy utilization is calculated by dividing laser energy by stone volume (J/mm3). This is a measure of how much laser energy is needed to break down a stone. | Intraoperatively (Day 1) |