A Trial Comparing Efficacy of HM3 Versus F2 Lithotripters for Stone Fragmentation

Study Overview
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Brief Summary
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The older lithotripter, HM3, has over 90% stone-free rate in most studies. However, it's less transportable than the new model, F2. There are no prospective trials performed to make a valid comparison between these 2 lithotripters in terms of efficacy of stone fragmentation and clinical outcomes.

Detailed Description
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Shock wave kidney stone treatment was introduced in the 1980's. It is the least invasive method to treat kidney stone disease. The unmodified Dornier HM3 has over 90% stone free rate in most studies. The MH3 requires immersion in a full bath, necessitating dedicated operative space. The new generation model F2 uses water cushion as a coupling medium and is easily transported. The generators used in both machines are also different. The newer model has the advantage of being more convenient due to portability and ease of use of the coupling medium, but there have been no prospective studies to compare these 2 machines in terms of efficacy of stone fragmentation and clinical outcomes. We seek to compare the HM3 with the F2 models in terms of stone free rates, complications and clinical outcomes to determine which machine is the most effective and will limit the need for additional stone procedures.

Official Title
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A Randomized Controlled Trial Comparing Efficacy of HM3 vs F2 Lithotripters for Stone Fragmentation

Conditions
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Urolithiasis

Intervention / Treatment
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* Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with urolithiasis and choose to have ESWL treatment Age 18-90 years old Able to understand the informed consent Exclusion Criteria: Minors Cognitively impaired

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: Using HM3 lithotripter<br>This is an older generation lithotripter | Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)<br>* Using electric shock wave to treat urolithiasis<br>|
| Active Comparator: F2 lithotripter<br>This is a newer generation lithotripter | Procedure: Extracorporeal Shock Wave Lithotripsy (ESWL)<br>* Using electric shock wave to treat urolithiasis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rate, complications and need for ancillary procedures |  | 3-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal stones, lithotripsy, stone free rate