Moses vs. Thulium Laser Study

Study Overview
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Brief Summary
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The incidence of urinary tract stone disease is increasing. According to the National Health and Nutrition Examination Survey, as of 2012, 10.6% of men and 7.1% of women in the United States are affected by renal stone disease. This has led to an increased demand on Urologists for efficient and safe surgical treatment of stone disease. Over the past two decades, ureteroscopy with laser lithotripsy has become the treatment of choice for most ureteral and renal stones globally. The holmium laser is considered the gold standard for laser lithotripsy. Holmium laser lithotripsy with Moses and the thulium laser are new technologies meant to improve the efficiency of laser lithotripsy. Both are FDA approved treatment modalities for stone disease. Two in vitro studies have compared Moses versus thulium and shown that thulium has higher ablative volumes then the holmium laser with Moses, but no clinical trials have compared the two treatment modalities. In this study, investigators are going to conduct a prospective, randomized clinical trial to determine whether there is a difference in procedural time, intraoperative parameters or stone free rate between the Holmium laser with Moses and the thulium laser. This is significant as this may lead to shorter overall operative times, which may result in decreased operative costs and complications.

Official Title
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Randomized Clinical Trial Evaluating the Efficiency and Safety of Holmium Laser With Moses Technology Versus SuperPulsed Laser System With Thulium Laser on Renal and Ureteral Stones

Conditions
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Urinary Tract Stone

Intervention / Treatment
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* Device: Holmium laser with Moses lasers
* Device: Holmium laser with thulium lasers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with renal or ureteral urinary stones who require endoscopic treatment in the outpatient operating room Participant's stone size in a single renal unit of 3-10 mm and 11-20 mm. Stone size is defined as the largest diameter of a single stone on pre-operative CT. Participants with multiple stones will be included as long as their largest stone size falls within the above parameters. Exclusion Criteria: Participants under 18 years of age and over 89 years old. Pregnant participants Participants with transplant kidneys Participants with irreversible coagulopathy Participants with known ureteral stricture disease Participants who do not have a pre-operative CT. Non-English speaking, vulnerable participants such as lacking of decision-making capability, prisoner, adult unable to consent, will not be enrolled.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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
Interventional Model Description: Participants will be randomized (ratio 1:1) at the time of enrollment to be treated with either the holmium laser with Moses or the thulium laser. Investigators will use Permuted Block Randomization (stratified by stone size 3 - 10 mm or 11-20 mm) (block size 4).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants treated with Holmium laser with the Moses laser<br> | Device: Holmium laser with Moses lasers<br>* The holmium laser with Moses is FDA approved. It emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. The goal is to increase stone ablative volume and decrease retropulsion of the stone.<br>|
| Experimental: Participants treated with Holmium laser with the thulium laser<br> | Device: Holmium laser with thulium lasers<br>* The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Time (Minutes) | Time from the minute the ureteroscope is inserted into the participant to the time the ureteroscope has been removed will be reported as procedural time. | up to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone Free Rate | Stone free rate (SFR) (%) are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the urinary tract which were defined as ≦ 4mm, asymptomatic, non-obstructive and non-infectious stone particles. | Baseline(pre-operative) and approximately 8 weeks | 
| Lasing Time (Minutes) | Time the laser was in use, not including pedal pauses | up to 6 hours | 
| Total Energy Used (Kilojoules) | The total energy used to fragment the stones into small pieces (≤2 mm) | up to 6 hours | 
| Ablation Efficiency (J/mm^3) | It is a ratio of ablated stone volume to the laser pulse energy (J/mm3) | up to 6 hours | 
| Number of Participants With Post-operative Complications |  | approximately 8 weeks (1 month post-operative) | 
| Change in Quality of Life Survey (WISQOL Short Form) Both Pre-operatively and Post-operatively | WISQOL short form is a 6 item questionnaire which can be scored from 1(worst outcome) to 5 (best outcome). The raw score range is 5-30. In the study, standardized total score is used. the range of the standardized total score is 0-100. | Baseline(pre-operative) and approximately 8 weeks (1 month post-operative) | 
| Score on the Laser Evaluation Instrument | Physician evaluation of the laser will be done by Laser Evaluation Instrument. It consists of 6 items which can be scored from 0(worst outcome) to 5 (best outcome). Cumulative score may range from 0-30. | Up to 6 hours | 
| Ablation Speed | The speed to fragment or dust stones | 0-6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lithotripsy, Holmium laser