Comparison of Lithotripsy Urolithiasis Machines

Clinical Trial ID: NCT04069338

Description

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

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.


Criteria

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.

  • Start Date

    2019-05-31

  • Last Updated

    2019-08-23

  • Sponsor

    The Cleveland Clinic

  • Condition Name

    Urolithiasis

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