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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 6 7 8}

How 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. ^{1 2 4 5 6}

Research Team

Naeem Bhojani, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility 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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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) 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 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]

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]

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]

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 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]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Flexible ureteroscopy for lower pole renal stones: novel superpulse thulium (TM) fiber laser lithotripsy]. [2021]

2. Italy 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. [2023]

3. India 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. [2022]

4. England 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Ex vivo testing of air-cooled CW/modulated 30 W thulium fiber laser for lithotripsy. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Collateral damage to the ureter and Nitinol stone baskets during thulium fiber laser lithotripsy. [2016]

7. China pubmed.ncbi.nlm.nih.gov

[Efficacy and safety of superpulse thulium laser lithotripsy in the intracavitary treatment of urinary calculi]. [2023]

8. India pubmed.ncbi.nlm.nih.gov

The clinical efficiency and safety of 60W superpulse thulium fiber laser in retrograde intrarenal surgery. [2022]