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Laser
TFL vs MOSES Laser for Kidney Stones
N/A
Recruiting
Led By Hazem Elmansy, MD
Research Sponsored by Thunder Bay Regional Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients referred with single kidney stones of 10-20 mm in its largest diameter, or multiple stones involving a single calyx
18 years of age and over at the time of enrollment
Must not have
Patients with ipsilateral distal ureteral stones or stricture
Patients with solitary kidney
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intraoperative
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two laser types for treating kidney stones, to see which is safer and more effective.
Who is the study for?
This trial is for adults over 18 with kidney stones sized 10-20 mm or multiple stones in one calyx. They must understand and consent to the study, be able to follow its procedures, and not have had previous shock wave treatments for the same stone. Pregnant individuals, those with certain preexisting conditions, a solitary kidney, additional ureteral stones or strictures, very large or numerous differently located stones, untreated urinary infections or uncorrected bleeding disorders are excluded.
What is being tested?
The study compares two laser technologies: Thulium Fiber Laser (TFL) and MOSES Holmium Laser in treating kidney stones. It aims to determine which laser is more effective and safe for patients requiring removal of these stones through ureteroscopy.
What are the potential side effects?
While specific side effects aren't listed here, typical risks from laser treatment of kidney stones may include discomfort during urination, blood in urine post-procedure, potential infection risk due to surgery as well as possible injury to the kidneys or surrounding organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have kidney stones that are 10-20 mm large or multiple stones in one area.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a stone or narrowing in the tube on the same side as my bladder.
Select...
I have only one kidney.
Select...
I am able to understand and consent to the study in English.
Select...
I cannot stop my blood thinners before surgery.
Select...
I have had shock wave treatment for a kidney stone before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ intraoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intraoperative
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Procedural Time
Secondary study objectives
Laser efficiency
Lasing time
Number of times the laser pedals are pressed
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Thulium Fibre Laser (TFL)Experimental Treatment1 Intervention
Patients randomized to this arm will undergo treatment using the TFL.
Group II: MOSES Holmium LaserExperimental Treatment1 Intervention
Patients randomized to this arm will undergo treatment using the MOSES Holmium laser.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thulium Fibre Laser
2022
N/A
~190
Find a Location
Who is running the clinical trial?
Thunder Bay Regional Health Research InstituteLead Sponsor
10 Previous Clinical Trials
687 Total Patients Enrolled
1 Trials studying Kidney Stones
76 Patients Enrolled for Kidney Stones
Thunder Bay Regional Research InstituteLead Sponsor
8 Previous Clinical Trials
445 Total Patients Enrolled
1 Trials studying Kidney Stones
76 Patients Enrolled for Kidney Stones
Hazem Elmansy, MDPrincipal InvestigatorUrologist
4 Previous Clinical Trials
384 Total Patients Enrolled
1 Trials studying Kidney Stones
76 Patients Enrolled for Kidney Stones