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Laser Therapy
Thulium Fiber Laser for Kidney Stones (TFL Trial)
N/A
Recruiting
Led By Naeem Bhojani, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bilateral ureteroscopy will be permitted but only the first side will be included in the study
Must be a suitable operative candidate for flexible ureteroscopy per urologic guidelines
Must not have
Untreated Urinary Tract Infection (UTI)
Neurogenic bladder or spinal cord injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the procedure
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new technique to help break up kidney stones without surgery.
Who is the study for?
This trial is for adults who can consent to treatment, have kidney stones between 8-20 mm in size suitable for ureteroscopy, and meet specific health guidelines. It's not open to those with neurogenic bladder conditions, spinal cord injuries, pregnancy, untreated UTIs or a history of certain urinary tract procedures.
What is being tested?
The study is evaluating the effectiveness of Thulium Fiber Laser (TFL) technology in breaking down kidney stones during ureteroscopy—a procedure where a small scope is used to locate and remove stones from the urinary tract.
What are the potential side effects?
While the side effects are not detailed here, typical risks associated with laser lithotripsy may include discomfort during urination, bleeding around the stone fragments, and possible infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a procedure to look inside my ureters, but only one side will be studied.
Select...
I am considered fit for a specific kidney stone removal surgery.
Select...
I have a kidney stone or multiple stones that together are 8-20 mm in size.
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 currently have a urinary tract infection that hasn't been treated.
Select...
I have a bladder condition due to nerve problems or a spinal cord injury.
Select...
I have stones in my ureter.
Select...
I have had surgery on the urinary tract or a narrow ureter on one side before.
Select...
I have had radiation therapy to my abdomen or pelvis before.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean total operative time
Secondary study objectives
Rate of stone retropulsion
Other study objectives
Mean length of hospitalization
Mean perceived workload score
Rate of need for ancillary procedures
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: LithotripsyExperimental Treatment1 Intervention
Ureteroscopy with lithotripsy using the Thulium Fiber Laser
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,362 Previous Clinical Trials
3,065,811 Total Patients Enrolled
9 Trials studying Kidney Stones
3,424 Patients Enrolled for Kidney Stones
University of California, San DiegoOTHER
1,189 Previous Clinical Trials
1,587,591 Total Patients Enrolled
9 Trials studying Kidney Stones
4,078 Patients Enrolled for Kidney Stones
Columbia UniversityOTHER
1,498 Previous Clinical Trials
2,768,831 Total Patients Enrolled
3 Trials studying Kidney Stones
248 Patients Enrolled for Kidney Stones
University of British ColumbiaOTHER
1,481 Previous Clinical Trials
2,494,766 Total Patients Enrolled
13 Trials studying Kidney Stones
4,581 Patients Enrolled for Kidney Stones
Vanderbilt UniversityOTHER
710 Previous Clinical Trials
6,143,230 Total Patients Enrolled
2 Trials studying Kidney Stones
86 Patients Enrolled for Kidney Stones
The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,610 Total Patients Enrolled
6 Trials studying Kidney Stones
3,666 Patients Enrolled for Kidney Stones
Ohio State UniversityOTHER
871 Previous Clinical Trials
655,582 Total Patients Enrolled
3 Trials studying Kidney Stones
326 Patients Enrolled for Kidney Stones
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
380 Previous Clinical Trials
131,439 Total Patients Enrolled
3 Trials studying Kidney Stones
193 Patients Enrolled for Kidney Stones
Naeem Bhojani, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
3 Previous Clinical Trials
273 Total Patients Enrolled
1 Trials studying Kidney Stones
43 Patients Enrolled for Kidney Stones
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am having a procedure to look inside my ureters, but only one side will be studied.I am considered fit for a specific kidney stone removal surgery.I currently have a urinary tract infection that hasn't been treated.I have a bladder condition due to nerve problems or a spinal cord injury.I have a kidney stone or multiple stones that together are 8-20 mm in size.I am 18 years old or older.I have stones in my ureter.I have had surgery on the urinary tract or a narrow ureter on one side before.I have had radiation therapy to my abdomen or pelvis before.
Research Study Groups:
This trial has the following groups:- Group 1: Lithotripsy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.