SP TLF Versus Ho:YAG Laser

Study Overview
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Brief Summary
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The investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters leading to more efficient (4 times more) and effective stone dusting resulting in production of finer dust particles obviating the need for postoperative ureteric stenting which remains a major source of patient discomfort.

Official Title
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Comparative Effectiveness of the Super Pulse Thulium Fiber Laser (SP TLF) for Laser Lithotripsy of Urinary Calculi

Conditions
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Urinary Calculi

Intervention / Treatment
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* Device: Laser lithotripsy (SP TLF)
* Device: Laser lithotripsy (Ho:YAG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is scheduled to undergo mini-PCNL and/or RIRS surgery at the University of Rochester Medical Center for the management of upper urinary tract calculi (i.e. kidney and proximal ureter) Stones located in the kidney and proximal ureter Stones measuring 10-30mm Ability to give informed consent Any racial or ethnic origin Age 18 years and older Exclusion Criteria: Active kidney infection Patients with prior stenting Pregnant patients Patients with solitary kidney Patients with ureteral tumor or stricture Inability to give informed consent Not age 18 and older

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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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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Super Pulse Thulium fiber Laser<br> | Device: Laser lithotripsy (SP TLF)<br>* Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)<br>|
| Active Comparator: Holmium: Yttrium-Aluminium-Garnet Laser<br> | Device: Laser lithotripsy (Ho:YAG)<br>* Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficiency of SP TFL in dusting stones | We plan to assess the direct impact of SP TFL to efficiently dust 10-30mm stones in the upper urinary tract . Metrics include time needed to ablate the stone i.e. ablation speed (stone volume mm3/sec) | 6 months | 
| Mean ablation energy needed to ablate stone volume | We plan to assess the direct impact of SP TFL to effectively dust 10-30mm stones in the upper urinary tract . Metrics include ablation energy needed to ablate the stone volume (Stone volume mm3/Joules) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of stones cleared. | We plan to assess the direct impact of SP TFL to produce finer quality dust following disregarding of 10-30mm stones in the upper urinary tract that can spontaneously pass without the need for stenting . Metrics will be stone clearance on postoperative CT scans | 9 months | 
| Number of participants reporting complications. | We plan to assess the direct impact of SP TFL to safely dust 10-30mm stones in the upper urinary tract . Metrics collected will include review of medical record for the presence of complications (e.g. infection, sepsis, obstruction etc.) for 3 months postoperative related to laser lithotripsy. | 9 months |