Thulium Fiber Laser for Kidney Stones
(TFL Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Disqualifiers: Ureter stones, Prior reconstructive procedures, Radiotherapy, Neurogenic bladder, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a multi-center, prospective clinical trial to assess the effect of TFL for the lithotripsy of kidney stones.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the Thulium Fiber Laser treatment for kidney stones?
Research shows that the Thulium Fiber Laser (TFL) is effective in breaking down small kidney stones with low complication rates. It has advantages like higher absorption, smaller fibers, and better pulse rate compared to other lasers, making it a promising option for treating kidney stones.
12345Is the Thulium Fiber Laser safe for treating kidney stones?
The Thulium Fiber Laser (TFL) has been studied for safety in treating kidney stones, showing it is generally safe with some minor complications. In one study, 61.8% of patients experienced mild postoperative issues, but no major equipment failures occurred during procedures.
12678How does the Thulium Fiber Laser treatment for kidney stones differ from other treatments?
The Thulium Fiber Laser (TFL) is unique because it uses a specific wavelength (1.94 μm) that allows for more precise and efficient stone fragmentation with less retropulsion (movement of the stone during treatment) compared to traditional lasers like the Holmium:YAG. It also uses smaller fibers, which can be beneficial in accessing challenging areas like lower pole kidney stones.
12456Eligibility Criteria
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.Inclusion 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 have a kidney stone or multiple stones that together are 8-20 mm in size.
+2 more
Exclusion Criteria
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 stones in my ureter.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Ureteroscopy with lithotripsy using the Thulium Fiber Laser
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 weeks
Medical chart review and post-operative CT imaging
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: LithotripsyExperimental Treatment1 Intervention
Ureteroscopy with lithotripsy using the Thulium Fiber Laser
Thulium Fiber Laser is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Thulium Fiber Laser for:
- Kidney stone lithotripsy
🇪🇺 Approved in European Union as Thulium Fiber Laser for:
- Kidney stone lithotripsy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centre Hospitalier de l'Université de MontréalMontreal, Canada
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Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
Mayo ClinicCollaborator
University of California, San DiegoCollaborator
Columbia UniversityCollaborator
University of British ColumbiaCollaborator
Vanderbilt UniversityCollaborator
The Cleveland ClinicCollaborator
Ohio State UniversityCollaborator
References
[Flexible ureteroscopy for lower pole renal stones: novel superpulse thulium (TM) fiber laser lithotripsy]. [2021]The SuperPulse Thulium (Tm) fiber laser (wavelength of 1.94 m) has been recently introduced as a directed-energy source for urology. Preclinical studies have shown a significant potential of the SuperPulse Tm fiber laser (SP TFL) for lithotripsy. However, clinical reports of using SP TFL to treat urolithiasis are still few and limited. Of special interest are challenging cases, e.g., lower pole stones, when extreme deflection of the instrument is required.
Comparing outcomes of thulium fiber laser versus high-power Holmium:YAG laser lithotripsy in pediatric patients managed with RIRS for kidney stones. A multicenter retrospective study. [2023]The aim of this study was to evaluate thulium fiber laser (TFL) safety and efficacy compared to high-power (HP) Holmium:YAG laser in pediatric patients who have undergone retrograde intrarenal surgery (RIRS) for kidney stones.
Thulium fiber laser versus holmium:yttrium aluminum garnet laser for stone lithotripsy during mini-percutaneous nephrolithotomy: A prospective randomized trial. [2022]We aimed to evaluate the effectiveness and safety of the newly launched thulium fiber laser (TFL) with holmium laser lithotripsy in the miniaturized percutaneous nephrolithotomy (Miniperc) procedure for renal stones.
Super pulsed thulium fiber laser outcomes in retrograde intrarenal surgery for ureteral and renal stones: a systematic review and meta-analysis. [2023]Laser lithotripsy using a thulium fiber laser (TFL) has become an effective treatment option for small renal stones with low complication rates. TFL has a higher absorption coefficient, smaller fibers, and better pulse rate capability.
Ex vivo testing of air-cooled CW/modulated 30 W thulium fiber laser for lithotripsy. [2019]A diode-pumped, air-cooled, all-fiber, quasi-continuous-wave thulium laser at an operating wavelength of 1.94 μm has been designed to study the performance of the laser parameter on the rate of fragmentation and its dependence on stone composition, fragmented particle size, as well as the retropulsion effect. The optimized laser cavity with an active fiber core/cladding diameter of 10/130 μm under a counter-propagating pump provides a stable laser power of 30 W at a slope efficiency of 50% and wall plug efficiency of 17%. The rate of fragmentation along with the retropulsion effect has been studied with human calcium oxalate monohydrate (COM) urinary stones (N=36) of different composition by using the designed laser and 200-μm-core low OH silica delivery fiber. The thulium fiber laser setting of 2.7 J pulse energy at the pulse rate of 10 Hz, pulse width of 90 ms, and peak power of 30 W is successful in breaking human COM stones in a controlled manner at a fragmentation rate of 0.8±0.4 mg/s, with almost uniform fragments of particle size less than 1.6 mm. During the stone fragmentation, the stone displacement (retropulsion effect) is less than 15 mm, even for the fragmented stone mass of 15±5 mg.
Collateral damage to the ureter and Nitinol stone baskets during thulium fiber laser lithotripsy. [2016]The experimental Thulium fiber laser (TFL) is currently being studied as a potential alternative lithotripter to the clinical gold standard Holmium:YAG laser. Safety studies characterizing undesirable Holmium:YAG laser-induced damage to ureter tissue and stone baskets have been previously reported. Similarly, this study characterizes TFL induced ureter and stone basket damage.
[Efficacy and safety of superpulse thulium laser lithotripsy in the intracavitary treatment of urinary calculi]. [2023]Objective: To evaluate the efficacy and safety of superpulse thulium laser lithotripsy in the intracavitary treatment of urinary calculi. Methods: From May 2021 to July 2022, patients diagnosed with urinary calculi were screened in four medical centers. Those who met the criteria were treated with superpulse thulium fiber laser under endoscope. The patients' perioperative conditions were recorded. The main effective index was stone-free rate (SFR) 4 weeks after operation, the main safety index was the failure rate of the experimental instruments during operation, and the secondary safety index was the incidence rate of perioperative complications. Results: A total of 76 eligible patients completed superpulse thulium fiber laser lithotripsy, with an average age of (52.0±11.1) years, 54 males and 22 females. There were 31 renal stones, 43 ureteral stones and 2 bladder stones. Percutaneous nephrolithotomy was performed in 17 patients. Ureteroscopy lithotripsy/flexible ureteroscopy lithotripsy was performed in 57 patients and transurethral bladder lithotripsy was in 2 patients. The lithotripsy time of all patients was (50.9±31.4) minutes. There was no failure of experimental instruments during the operation. Six patients refused follow-up examination after operation. The incidence of postoperative adverse events was 61.8% (47/76). One patient needed hospitalization due to inguinal hernia after operation, and the rest were classified as Clavien-dindo grade 1-2. The SFR was 94.3% (66/70) at 4 weeks after operation. Conclusion: It is effective and safe to use superpulse thulium fiber laser in the treatment of urinary calculi.
The clinical efficiency and safety of 60W superpulse thulium fiber laser in retrograde intrarenal surgery. [2022]Our aim is to evaluate the clinical efficiency and safety of 60W Thulium fiber laser (TFL) during retrograde intrarenal surgery (RIRS). The performance of the TFL across different ranges of stone volumes and stone densities is assessed.