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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 below
Select...
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 weeks
Treatment ~ Varies
Follow Up ~at 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 weeks for reporting.

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 more

Awards & 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
3,342 Previous Clinical Trials
3,062,182 Total Patients Enrolled
9 Trials studying Kidney Stones
3,424 Patients Enrolled for Kidney Stones
University of California, San DiegoOTHER
1,180 Previous Clinical Trials
1,574,897 Total Patients Enrolled
7 Trials studying Kidney Stones
3,978 Patients Enrolled for Kidney Stones
Columbia UniversityOTHER
1,486 Previous Clinical Trials
2,663,040 Total Patients Enrolled
3 Trials studying Kidney Stones
248 Patients Enrolled for Kidney Stones

Media Library

Thulium Fiber Laser (Laser Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05814133 — N/A
Kidney Stones Research Study Groups: Lithotripsy
Kidney Stones Clinical Trial 2023: Thulium Fiber Laser Highlights & Side Effects. Trial Name: NCT05814133 — N/A
Thulium Fiber Laser (Laser Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05814133 — N/A
~12 spots leftby Jan 2025
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