Trial Comparing Three Different Devices for Kidney Stone Removal During Percutaneous Surgery

Study Overview
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Brief Summary
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The investigators plan to compare three different devices that are used to break up large kidney stones during surgery for removal to see if one is faster or more efficient than the others.

Detailed Description
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Large kidney stones can be removed by a surgical procedure where a small puncture is made through the back into the kidney (percutaneous nephrolithotomy or PNL) but the stones usually need to be broken into smaller pieces before they can be removed through the small surgical incision. There are a number of FDA approved devices commercially available used to break up the stones including pneumatic, ultrasonic, and a combination of the two. Each technology has advantages and disadvantages. In the last few years there have been new, improved versions of these devices introduced. These improved versions have addressed previous issues of probes clogging or breaking and cumbersome handpiece design. These include the Cyberwand (Cybersonics, Erie, PA), a dual probe ultrasonic device, Swiss Lithoclast Select (EMS, Switzerland) combining the pneumatic and ultrasonic modalities, and a novel device by LMA (Gland, Switzerland) called the StoneBreakerTM, a portable pneumatic device powered by CO2 cartridges. We propose to compare each of these devices in a randomized study to see if one is better than another at removing kidney stones quickly and efficiently.

Official Title
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Randomized Controlled Trial Comparing Three Different Modalities of Newer Lithotrites For Intracorporeal Lithotripsy

Conditions
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Kidney Stones

Intervention / Treatment
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* Device: Cyberwand
* Device: Stonebreaker
* Device: Lithoclast Select


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo percutaneous nephrolithotomy for at least one kidney stone measuring 2 cm or greater Stone easily visible/measurable on plain abdominal imaging (KUB) or CT scan preoperatively Age 18 years or older Able to give informed consent Exclusion Criteria: Size of single largest stone less than 2 cm Pregnancy Active urinary tract infection Extracorporeal shockwave lithotripsy within the last three months Complex stone anticipating multiple access sites Stones that are not clearly able to be measured on KUB or CT scan Inability to give informed consent Age less than 18 years

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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stonebreaker<br>Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented. | Device: Stonebreaker<br>* Stonebreaker will be used to break up the kidney stone. Duration will be timed and documented.<br>|
| Active Comparator: Lithoclast Select<br>Lithoclast Select will be used to breakup and remove kidney stone. Duration will be timed and documented. | Device: Lithoclast Select<br>* Lithoclast Select will be used to break up and remove the kidney stone. Duration will be timed and documented<br>|
| Active Comparator: Cyberwand<br>The dual probe Cyberwand device will be used to fragment and remove the kidney stone. Duration will be timed and documented. | Device: Cyberwand<br>* Dual probe lithotrite Cyberwand will be used to remove kidney stone. Duration will be timed and documented.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone Clearance Time in mm2/Min | Clearance rate was calculated by dividing the surface area of the targeted stone (mm2) by the total clearance time (min) | collected intraoperatively from the time stone breakage begins to end of stone removal with a stone extraction basket | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone-free After First Procedure | Number of participants deemed stone-free after initial stone-removal surgery | Post-operative Day 1 | 
| Secondary Procedure Required | Number of participants who required a secondary kidney stone removal procedure | Within three days of initial procedure | 
| Ureteral Stent Placed | Participants requiring a ureteral stent to be placed after initial stone removal procedure | Intra-operatively | 
| Nephrostomy Tube Placed | Participants requiring a nephrostomy tube to be placed at the end of the initial stone removal procedure | Intra-operatively | 
| Use of Other Device | Number of participants in which another stone breakage device was used in addition to the study-assigned lithotrite | Intra-operatively | 
| EBL>400mL | Number of participants with an estimated blood loss greater than 400mL | Intra-operatively | 
| RBC Transfusion | Number of participants who required a blood transfusion post-operatively | Post-operatively <24 hours | 
| Length of Stay | Number of days participants were in hospital. Operative day is Day 1. | Post-operatively | 
| Post-operative Complications | Number of participants who experienced surgery-related post-op complications | Post-operative Days 2 and 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney stones, intracorporeal lithotriptors, kidney stone removal