Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
NCT Number: NCT04069338
A comparison on the outcomes of patients undergoing shockwave lithotripsy using the Storz machine versus the Dornier machine.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study.
Exclusion criteria
Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
Time frame: Four weeks post operative
Presence of stone on follow up imaging
Time frame: Intra-operative
Length of fluoroscopy exposure
Time frame: Intra-operative
Length of surgical procedure
Time frame: Four days post-operative
Response to visual analog scale
Time frame: One month post-operative
Medical complications
Time frame: One month post-operative
Follow up surgery
The Cleveland Clinic
Other
Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines
Acronym: CoLUM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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