Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

Study Overview
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Brief Summary
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Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.

Official Title
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Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

Conditions
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Stone Clearance

Intervention / Treatment
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* Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject will be older than 18 years of age Subject was diagnosed with renal calculi meeting the following criteria: Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT. Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm. Subject is a candidate for FURS procedure Subject is willing and has signed the Informed Consent Form Exclusion Criteria: Subject has undergone a previous treatment for stones in the same kidney Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session. Female subject is pregnant Concomitant anticoagulant medication that cannot be suspended during surgery

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: Stone breaking<br>Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters. | Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber<br>* The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.<br>|
| Experimental: Stone dusting<br>Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters. | Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber<br>* The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone Clearance | stone clearance will be confirmed by CT or X-Ray at 1 month follow up. | Stone clearance based on 1 month follow-up imaging data as compared to baseline | 
| Duration of catheterization time | Duration of catheterization will be measured to evaluate treatment efficiency | Change from 1 month to baseline | 
| Procedure time | duration of the procedure as an indicator for treatment efficiency. | during the procedure | 
| Usage of alternative stone extracting devices | The need of the surgeon to use baskets, forceps or saline flushing to achieve complete stone clearance. This outcome can influence both procedure time and further complication. | as measured during the procedure | 
| hospital stay | hospital duration will be measured to evaluate treatment efficiency | Change from 1 month to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Complications | Intraoperative Complications will be evaluated based on Modified Clavien Classification- Modified Clavien Grading: Grade 1,Grade 2,Grade 3,Grade 3a,Grade 3b,Grade 4,Grade 4a, Grade 4b, Grade 5. | during the procedure and during 1 month follow up | 
| Visibility during procedure | clear vision of the stone and organ compartments as reflected via endoscope and video screen. | during the procedure | 
| Occurrence of retropulsion that interferes with procedure | The subjective degree of stone movement and migration as a result of the laser treatment that interfere with procedure flow. | during the procedure | 
| Fiber performance | The surgeon will evaluate the degree of Fiber flexibility with scope deflection- and any damage to fiber, Fiber durability- deflection without losing energy/ efficiency and any Damage to scope. | during the procedure |