Thulium Fiber Laser for Kidney Stones

(TFL Trial)

Overseen By Kahina Bensaadi, DESS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Ureter stones, Prior reconstructive procedures, Radiotherapy, Neurogenic bladder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for breaking up kidney stones using a Thulium Fiber Laser. The goal is to evaluate the laser's effectiveness for individuals requiring lithotripsy, a procedure that uses lasers to shatter stones. Ideal participants have a single kidney stone or multiple stones with a combined size of 8 to 20 mm and qualify for a flexible ureteroscopy procedure, a common treatment for viewing and treating kidney stones. As an unphased trial, this study allows participants to contribute to innovative research that could enhance future kidney stone treatments.

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 prior data suggests that the Thulium Fiber Laser is safe for lithotripsy?

Research has shown that the Thulium Fiber Laser (TFL) is generally safe for treating kidney stones. Studies have found it effective for breaking up stones, with most patients likely to become stone-free. Another review suggested that TFL could be a breakthrough in kidney stone treatment, showing promising results with few complications. Overall, these findings indicate that TFL is well-tolerated and has few side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Thulium Fiber Laser is unique because it offers a more precise and efficient way to break down kidney stones during ureteroscopy. Unlike traditional Holmium lasers, which are commonly used for this condition, the Thulium Fiber Laser provides continuous laser emission, allowing for smoother and faster fragmentation of stones. Researchers are excited about this treatment because it has the potential to reduce procedure times and improve patient outcomes by minimizing tissue damage and enhancing stone clearance.

What evidence suggests that the Thulium Fiber Laser is effective for kidney stones?

Research has shown that the Thulium Fiber Laser (TFL), which participants in this trial will receive, effectively breaks up kidney stones. Studies indicate it can treat small kidney stones with few complications. For stones about 5 to 20 mm in size, the TFL performs as well as the Holmium:YAG laser, a common treatment. Its promising results have led some to view it as a potential "game-changer" for kidney stone treatment. The TFL's ability to break stones into dust makes it a reliable choice for those with kidney stones. ^{1 6 7 8 9}

Who Is on the Research Team?

Naeem Bhojani, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Thulium Fiber Laser

Trial Overview 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.

How Is the Trial Designed?

Group I: Lithotripsy Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

University of British Columbia

Collaborator

Trials

1,506

Recruited

2,528,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

The thulium fiber laser (TFL) significantly reduced stone disintegration time in the miniaturized percutaneous nephrolithotomy (Miniperc) procedure, averaging 11 minutes compared to 20 minutes with the holmium laser, indicating greater efficiency in treating renal stones.

While TFL showed a higher stone-free rate (94.9% vs. 90.9% for holmium), it was associated with a higher incidence of self-limiting postoperative hematuria, suggesting a trade-off between efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thulium fiber laser versus holmium:yttrium aluminum garnet laser for stone lithotripsy during mini-percutaneous nephrolithotomy: A prospective randomized trial. Mahajan, AD., Mahajan, SA.[2022]

The 60W Thulium fiber laser (TFL) demonstrated high efficacy in treating renal stones during retrograde intrarenal surgery (RIRS), achieving a stone-free rate of 93.6% across 126 patients with stones under 20 mm in size.

The laser's efficiency improved for larger stone volumes, while stone density did not significantly affect its performance, and the complication rate was low, with no serious complications beyond Clavien grade 2.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical efficiency and safety of 60W superpulse thulium fiber laser in retrograde intrarenal surgery. Vaddi, CM., Ramakrishna, P., Ganeshan, S., et al.[2022]

The systematic review and meta-analysis of 12 studies showed that retrograde intrarenal surgery (RIRS) using a thulium fiber laser (TFL) achieved a high stone-free rate of approximately 89.37%, indicating its effectiveness in treating renal and ureteral stones.

The procedure demonstrated low complication rates, primarily involving mild Clavien grade I-II complications, suggesting that TFL is a safe option for patients, although further large-scale randomized controlled trials are recommended for more comprehensive safety and efficacy data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Super pulsed thulium fiber laser outcomes in retrograde intrarenal surgery for ureteral and renal stones: a systematic review and meta-analysis. Almasoud, NA., Safar, O., Elatreisy, A., et al.[2023]

In a study of 126 pediatric patients undergoing retrograde intrarenal surgery for kidney stones, both thulium fiber laser (TFL) and high-power Holmium:YAG laser were found to be safe and effective, with similar stone-free rates (81.4% for Holmium:YAG vs. 89.7% for TFL).

The TFL group had a significantly shorter operative time (49.5 minutes) and a lower re-intervention rate (6.89%) compared to the Holmium:YAG group (64.3 minutes and 14.4%, respectively), suggesting TFL may offer advantages in surgical efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Candela, L., Solano, C., Castellani, D., et al.[2023]

The Thulium fiber laser (TFL) demonstrated longer ureter perforation times compared to the Holmium:YAG laser, suggesting it may be safer for use in lithotripsy procedures, with mean perforation times of 7.9, 3.8, and 1.8 seconds at pulse rates of 150, 300, and 500 Hz, respectively.

TFL showed reduced collateral damage to ureter tissue and stone baskets, with no damage observed at working distances greater than 1.0 mm, indicating a potentially greater safety margin compared to the standard Holmium:YAG laser.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collateral damage to the ureter and Nitinol stone baskets during thulium fiber laser lithotripsy. Wilson, CR., Hardy, LA., Irby, PB., et al.[2016]

The SuperPulse Thulium fiber laser (SP TFL) is an effective and safe treatment for small calyceal stones in the lower pole of the kidney, achieving a stone-free rate of 86.6% after 90 days in a study of 15 patients.

The use of small laser fibers allows for better maneuverability during flexible ureteroscopy, enabling successful treatment even in challenging anatomical conditions, with a low complication rate of 6.6%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Flexible ureteroscopy for lower pole renal stones: novel superpulse thulium (TM) fiber laser lithotripsy]. Rapoport, LM., Gazimiev, MA., Korolev, DO., et al.[2021]

In a study involving 76 patients treated with superpulse thulium fiber laser lithotripsy, the stone-free rate (SFR) was an impressive 94.3% four weeks post-operation, indicating high efficacy in treating urinary calculi.

The procedure demonstrated good safety, with no failures of experimental instruments during operations, although there was a 61.8% incidence of postoperative adverse events, mostly mild (Clavien-dindo grade 1-2).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of superpulse thulium laser lithotripsy in the intracavitary treatment of urinary calculi]. Liu, C., Shao, Y., Xia, L., et al.[2023]

The thulium laser designed for this study effectively fragmented human calcium oxalate monohydrate stones at a controlled rate of 0.8 mg/s, producing uniform fragments smaller than 1.6 mm, which is important for minimizing complications during procedures.

The laser demonstrated a minimal retropulsion effect, displacing stones less than 15 mm during fragmentation, which enhances safety and precision in treating urinary stones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ex vivo testing of air-cooled CW/modulated 30 W thulium fiber laser for lithotripsy. Pal, D., Chowdhury, SD., Dhar, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06721975

Thulium Fiber Laser (TFL) vs Thulio Pulsed ... This research study is being conducted to assess the ability and efficiency of two laser systems to break up kidney stones during ureteroscopy with laser ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10631031/

Super pulsed thulium fiber laser outcomes in retrograde ... Laser lithotripsy using a thulium fiber laser (TFL) has become an effective treatment option for small renal stones with low complication rates.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08362-9

Clinical efficacy and safety of the superpulse thulium fiber ... This study aims to evaluate and compare the clinical efficacy and safety of the SP TFL and HO:YAG for URS lithotripsy in the treatment of upper urinary calculi.

4. renalandurologynews.com renalandurologynews.com/reports/kidney-stone-holmium-yag-thulium-fiber-laser-similarly-effective-treatment-risk/

Holmium:YAG vs Thulium Fiber Laser Similarly Effective for ... Both lasers were found to be effective and efficient at dusting stones sized 5 to 20 mm located only in the kidney during outpatient flexible ...

5. journals.lww.com journals.lww.com/co-urology/fulltext/2021/03000/outcomes_of_thulium_fibre_laser_for_treatment_of.4.aspx

Outcomes of thulium fibre laser for treatment of urinary... Based on the review, the TFL is a potential game-changer for kidney stone disease and has a promising role in the future.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12366842/

Safety and efficacy of thulium fiber laser in ureteric calculi The objective of the study was to analyze the efficacy and safety of superpulsed thulium fiber laser (TFL) lithotripsy and to identify the ...

7. bmcurol.biomedcentral.com bmcurol.biomedcentral.com/articles/10.1186/s12894-023-01355-x

Super pulsed thulium fiber laser outcomes in retrograde ... This meta-analysis suggests that RIRS using TFL is an effective and safe treatment option for renal and ureteral stones, with high stone-free and low ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7879830/

Outcomes of thulium fibre laser for treatment of urinary tract ... Based on the review, the TFL is a potential game-changer for kidney stone disease and has a promising role in the future.

9. minervamedica.it minervamedica.it/en/journals/hellenic-urology/article.php?cod=R57Y2025N04A0146

Thulium fiber laser (TFL drive) for kidney and ureteral ... Data on patient demographics, stone parameters, laser settings, intraoperative and postoperative outcomes were collected. Complications were ...