Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2019-05-31
2022-10-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Device Storz Modulith SLX-F2
Patients receive standard of care treatment for their urolithiasis using the Device Storz Modulith SLX-F2
Lithotripter
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
Dornier Delta III Treatment
Patients receive standard of care treatment for their urolithiasis using the Dornier Delta III lithotripter
Lithotripter
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
Interventions
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Lithotripter
Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Principal Investigators
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Manoj Monga, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Locations
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Cleveland Clinic Foundation
Cleveland, Ohio, United States
Countries
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Other Identifiers
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19-619
Identifier Type: -
Identifier Source: org_study_id