Comparison of Lithotripsy Urolithiasis Machines

Study Overview
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Brief Summary
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A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.

Detailed Description
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This is a single institution, prospective randomized controlled clinical trial comparing two lithotriper machines (the Storz Modulith LX-F2 and Dornier Delta III) in patients who are undergoing shockwave lithotripsy (SWL) as the primary management of their urinary stone. Patients record pain score on day of operation and post-operative day 1, and are followed for 1 month until they receive standard of care imaging at 1 month post-operatively.

Official Title
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Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines

Conditions
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Kidney Calculi, Kidney Stone, Ureteral Calculi, Ureterolithiasis, Urolithiasis

Intervention / Treatment
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* Procedure: Lithotripter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Cleveland Clinic Foundation patients planned for elective SWL with a preoperative CT performed Age ≥ 18 years old Male and female patients Patients of all ethnic backgrounds Stone size 5-15mm Stone location: Renal or proximal ureter Stone density: < 1200 Hounsfield Units Skin to stone distance: < 12cm Primary treatment for a solitary stone (must be previously untreated) Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study. Exclusion Criteria: Prior treatment for specified stone Multiple stones on treatment side (even if only one is treated) Anticoagulated or history of coagulopathy Prior ureteral stent placement Technical problems/impossibility of localizing the stone on the day of intervention Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device Storz Modulith SLX-F2<br>Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2 | Procedure: Lithotripter<br>* Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines<br>|
| Active Comparator: Dornier Delta III Treatment<br>Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter | Procedure: Lithotripter<br>* Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate | Presence of stone on follow up imaging | Four weeks post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluoroscopy time | Length of fluoroscopy exposure | Intra-operative | 
| Treatment Time | Length of surgical procedure | Intra-operative | 
| Pain Scores | Response to visual analog scale | Four days post-operative | 
| Complication Rates | Medical complications | One month post-operative | 
| Secondary Interventions required | Follow up surgery | One month post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lithotripsy, Extracorporeal shockwave lithotripsy