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Laser Therapy
Stone dusting for Kidney Stone Removal
N/A
Waitlist Available
Research Sponsored by Lumenis Be Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from 1 month to baseline
Awards & highlights
Study Summary
Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.
Eligible Conditions
- Kidney Stone Removal
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from 1 month to baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from 1 month to baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of catheterization time
Procedure time
Stone Clearance
+2 moreSecondary outcome measures
Fiber performance
Intraoperative Complications
Occurrence of retropulsion that interferes with procedure
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Stone dustingExperimental Treatment1 Intervention
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Group II: Stone breakingExperimental Treatment1 Intervention
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
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Who is running the clinical trial?
Lumenis Be Ltd.Lead Sponsor
37 Previous Clinical Trials
1,393 Total Patients Enrolled
Lumenis Ltd.Lead Sponsor
23 Previous Clinical Trials
654 Total Patients Enrolled
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