Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare how well two treatments work for removing kidney stones. The two study groups include ureteroscopy with long/short pulse lithotripsy to remove kidney stones. Both of these options are considered standard of care and are used currently in surgery.

Detailed Description
-----------------
This study will compare two types of laser lithotripsy to see the pulse duration to determine which settings are more effective. This is a randomized control trial with subjects randomized to either long pulse or a short pulse group. Those subjects with a single kidney/ureter stone measuring up to 20 mm will be eligible for the study. The procedures will be performed using the standard of care instruments and techniques but the pulse type setting in surgery will be constant. Some Holmium laser devices provide the option to modulate the pulse duration. A longer laser pulse duration (700 μs or 1500 μs) as compared to a traditional pulse duration (300 μs or 350 μs) has been demonstrated in vitro studies to provide effective stone disintegration while reducing laser fiber tip degradation and stone retropulsion. Both the long and the short setting can dust the stone and currently we alternate in each procedure from one setting to the other and it is unclear which setting is more effective. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. All subjects will be seen one week to one month after surgery for stent removal and follow up.

Official Title
-----------------
Long Pulse Versus Short Pulse Laser Dusting for Renal Stones

Conditions
-----------------
Kidney Stone, Ureter Stone, Renal Stone

Intervention / Treatment
-----------------
* Device: Short Pulse Duration
* Device: Long Pulse Duration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney/ureter single stone between up to 2 cm Age over 18 years Two kidneys Exclusion Criteria: Solitary Kidney Age under 18 Pregnancy

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
Interventional Model Description: All subjects enrolled in the study will be randomized to either short pulse or long pulse for treatment of their stones. The date of treatment will be decided between the subject and the treating surgeon. All treatments will be performed using the standard of care and will be performed in the same fashion as procedures for patients not enrolled in the study. There is no modification of the techniques used to remove the stones. Post operatively, we plan to discharge all subjects home from the recovery unit. All subjects will be seen one week to one month after surgery for stent removal and a low dose CT of the abdomen and pelvis to assess stone free rates which is standard for all stone patients.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Short Pulse Duration Group<br>A short pulse duration (300 μs or 350 μs) will be used in this group. | Device: Short Pulse Duration<br>* The holmium laser device will be used on a short laser pulse duration setting (300 μs or 350 μs)<br>|
| Active Comparator: Long Pulse Duration Group<br>A long laser pulse duration (700 μs or 1500 μs) will be used in this group. | Device: Long Pulse Duration<br>* The holmuim laser device will be used on a long laser pulse duration setting (700 μs or 1500 μs)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Proportion of participants free of stones after procedure reported by group | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative duration time | Operative duration time measured by minutes | 1 month after surgery | 
| Need for Secondary Procedures | The number of participants needing additional secondary procedures will be reported per group | 1 month after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Basketing, Dusting, Holmium Laser, Laser Lithotripsy, Intracorporeal Lithotripsy, Urolithiasis