An interventional study of Lithotripter in Kidney Stone, Kidney Calculi and Ureteral Calculi, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Treatment
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.
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
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 the Device Storz Modulith SLX-F2
Procedure: Lithotripter
Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter
Procedure: Lithotripter
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
Stone free rate
Presence of stone on follow up imaging
Time frame: Four weeks post operative
Fluoroscopy time
Length of fluoroscopy exposure
Time frame: Intra-operative
Treatment Time
Length of surgical procedure
Time frame: Intra-operative
Pain Scores
Response to visual analog scale
Time frame: Four days post-operative
Complication Rates
Medical complications
Time frame: One month post-operative
Secondary Interventions required
Follow up surgery
Time frame: One month post-operative
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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