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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after the procedure
Awards & highlights
TFL Trial 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.Check my eligibility
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.See study design
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.
TFL Trial 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.
TFL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean total operative time
Secondary outcome measures
Rate of stone retropulsion
Other outcome measures
Mean length of hospitalization
Mean perceived workload score
Rate of need for ancillary procedures
+2 moreTFL Trial Design
1Treatment groups
Experimental Treatment
Group I: LithotripsyExperimental Treatment1 Intervention
Ureteroscopy with lithotripsy using the Thulium Fiber Laser
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Who is running the clinical trial?
Mayo ClinicOTHER
3,245 Previous Clinical Trials
3,783,291 Total Patients Enrolled
7 Trials studying Kidney Stones
3,318 Patients Enrolled for Kidney Stones
University of California, San DiegoOTHER
1,130 Previous Clinical Trials
1,552,706 Total Patients Enrolled
5 Trials studying Kidney Stones
3,562 Patients Enrolled for Kidney Stones
Columbia UniversityOTHER
1,439 Previous Clinical Trials
2,447,585 Total Patients Enrolled
2 Trials studying Kidney Stones
170 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.
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