Randomized Controlled Trial Comparing the Storz Modulith SLX-F2 and Dornier Delta III Lithotripter Machines
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- The Cleveland Clinic
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Stone free rate
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Device Storz Modulith SLX-F2
Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2
Intervention: Lithotripter (Procedure)
Dornier Delta III Treatment
Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter
Intervention: Lithotripter (Procedure)
Outcomes
Primary Outcomes
Stone free rate
Time Frame: Four weeks post operative
Presence of stone on follow up imaging
Secondary Outcomes
- Fluoroscopy time(Intra-operative)
- Secondary Interventions required(One month post-operative)
- Pain Scores(Four days post-operative)
- Treatment Time(Intra-operative)
- Complication Rates(One month post-operative)