Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi

Study Overview
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Brief Summary
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This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more.

Detailed Description
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This study will examine the effects of ureteroscopic lasing technique (dusting, fragmentation and a hybrid approach) on total lasing time and total energy in patients with a large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm and having mean Hounsfield units of 1000 or more. Additionally, we will observe the impact of these parameters on total operative time.

Official Title
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Ureteroscopic Laser Modality on Total Lasing Time and Total Energy in Patients With Large, Dense Renal Calculi

Conditions
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Renal Calculi

Intervention / Treatment
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* Device: MOSES laser system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between the ages of 18-80. Any gender, race or ethnicity may be included- these factors play a small, if any role on renal calculi formation and ability to withstand procedure. Must be suitable for a flexible ureteroscopy as determined by the MD Large renal calculi burden of single or multiple stones with the sum of its longest diameters between 10-20 mm An average stone density of at least 1000 Hounsfield units. Exclusion Criteria: Those with a stone burden less than 10mm or more than 20mm. Those with an average stone density below 1000 Hounsfield units. Patients who are dependent on mandatory anticoagulation therapies and cannot stop for surgery Patients that cannot undergo ureteral access sheath placement Patients with abnormal anatomy such as horseshoe kidney Patients with a history of: Ipsilateral upper urinary tract reconstructive procedures on the side of the renal calculi Ipsilateral ureteral strictures Prior radiotherapy of the abdomen or pelvis Neurogenic bladder Spinal cord injuries Those who are pregnant Currently being treated for infection or cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Flexible Ureteroscopy with Dusting<br>Flexible ureteroscopy with the dusting lasing technique. MOSES parameters will be set to an energy of 0.3-0.4 Jules and a frequency of 50-80 hertz | Device: MOSES laser system<br>* A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,<br>|
| Other: Flexible Ureteroscopy with Fragmentation<br>Flexible ureteroscopy utilizing the Fragmentation lasing technique. MOSES parameters will be set to 0.8-1 JULES and a frequency of 8-10 hertz | Device: MOSES laser system<br>* A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,<br>|
| Other: Flexible Ureteroscopy with Hybrid<br>Flexible ureteroscopy utilizing the Hybrid lasing technique which will use both sets of parameters. | Device: MOSES laser system<br>* A holmium laser technology widely used as the gold standard for laser lithotripsy for ureteroscopy treatment of renal calculi,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced OR time | Hybrid technique will result in overall reduced OR time | 2 hours | 
| Less Energy Transmission to Patient | Hybrid technique will have less energy transmission to the patient | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone Free |  | 1 month after surgery |