Status:
COMPLETED
Comparison of Lithotripsy Urolithiasis Machines
Lead Sponsor:
The Cleveland Clinic
Conditions:
Kidney Stone
Kidney Calculi
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.
Detailed Description
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 shockw...
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
May 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 12 2022
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04069338
Start Date
May 31 2019
End Date
October 12 2022
Last Update
December 13 2023
Active Locations (1)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195