TFL vs MOSES Laser for Bladder Cancer

Overseen By Shalyn Littlefield

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thunder Bay Regional Health Research Institute

Disqualifiers: Muscle-invasive tumors, Metastatic, Carcinoma in situ, others

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

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized clinical trial is to determine if there is difference in pathological and clinical outcomes between MOSES and TFL in the transurethral laser enucleation of bladder tumors. The main question it aims to answer is: Is there a difference in pathological and clinical outcomes between MOSES Holmium and Thulium Fiber Laser (TFL) in the transurethral laser enucleation of bladder tumors? Participants will randomized to either TFL of MOSES arm for their bladder resection procedure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the MOSES Laser treatment for bladder cancer?

Research shows that the MOSES Laser technology, when used for other conditions like stone disease, can be efficient in terms of procedure time and cost. Additionally, the MOSES technology has been compared favorably to other laser systems in terms of speed and cost-effectiveness for treating large bladder stones, suggesting potential benefits for bladder cancer treatment. ^{1 2 3 4 5}

Is the MOSES or TFL laser generally safe for use in humans?

The MOSES and TFL lasers have been studied for various conditions, such as stone disease and prostate enlargement, and have shown similar complication rates to other laser technologies, indicating they are generally safe for use in humans. ^{1 2 4 5 6}

What makes the MOSES Laser and TFL treatment unique for bladder cancer?

The MOSES Laser and TFL treatment for bladder cancer is unique because it uses advanced laser technology to potentially improve efficiency and reduce procedure time compared to traditional methods. The MOSES technology, in particular, is designed to enhance laser energy delivery, which may lead to faster and more cost-effective procedures. ^{1 2 3 4 7}

Research Team

Ahmed Z Ahmed

Principal Investigator

Thunder Bay Regional Health Sciences Centre

Eligibility Criteria

This trial is for adults over 18 who have visible bladder tumors identified by outpatient cystoscopy. It's not for those with urethral or upper urinary tract tumors, a history of carcinoma in situ, contracted bladder, or tumors unsuitable for laser resection like muscle-invasive or metastatic cancers.

Inclusion Criteria

Patients presented with visual criteria suggesting bladder tumor by outpatient cystoscopy will be eligible for inclusion

I am over 18 years old.

Exclusion Criteria

My tumor cannot be removed with laser surgery as determined by a urologist.

I have tumors in my urethra or upper urinary tract at the same time.

I have had a non-invasive type of cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bladder resection using either the Thulium Fiber Laser (TFL) or MOSES Holmium laser

Intraoperative

1 visit (in-person)

Follow-up

Participants are monitored for tumor recurrence and post-operative complications

12 weeks

Multiple visits (in-person)

Treatment Details

Interventions

• MOSES Holmium Laser
• TFL

Trial Overview The study compares two types of lasers: MOSES holmium and Thulium Fiber Laser (TFL), used in the transurethral enucleation of bladder tumors. Participants will be randomly assigned to either the TFL or MOSES group for their procedure.

Participant Groups

Group I: Thulium Fibre Laser Active Control 1 Intervention

Participants randomized to this arm will undergo bladder resection using the TFL laser

Group II: MOSES Holmonium Active Control 1 Intervention

Participants randomized to this arm will undergo bladder resection using the MOSES holmium laser.

MOSES Holmium Laser is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Approved in European Union as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Approved in Canada as Holmium Laser for:

• Kidney stones
• Benign prostatic hyperplasia (BPH)
• Urinary tract stones

Who Is Running the Clinical Trial?

Thunder Bay Regional Health Research Institute

Lead Sponsor

Trials

11

Recruited

860+

Findings from Research

In a study of 176 ureteroscopy cases, the use of Moses technology with the Lumenis Pulse P120H holmium laser did not significantly improve procedural efficiency compared to the regular mode, as measured by procedural time, fragmentation time, and energy used.

There were no significant differences in complication rates or stone-free rates between the Moses and regular modes, suggesting that while Moses technology may have potential benefits, they were not evident in this analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Impact of the Institution of Moses Technology on Efficiency During Retrograde Ureteroscopy for Stone Disease: Single-Center Experience. Knoedler, MA., Li, S., Best, SL., et al.[2022]

In a study comparing different lasers for treating bladder stones, the 120 W holmium laser with MOSES technology was the fastest, completing procedures in about 68.3 minutes, while the 30 W holmium laser took significantly longer at 297.5 minutes.

The thulium fiber laser (TFL) was faster than the 30 W holmium laser but less efficient than higher power lasers, and it was not cost-effective for large stones compared to the 100 W holmium laser, indicating that laser power is crucial for efficiency in these procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which Laser System Is Optimal for Cystolithotripsy of Large Bladder Calculi? Hajiha, M., Farkouh, A., Amasyali, AS., et al.[2023]

In a study of 41 patients with recurrent superficial bladder cancer treated with the holmium:YAG laser, the local recurrence rate was significantly lower (10%) compared to previous cystodiathermy treatments (32%), indicating improved efficacy of the laser treatment.

The holmium:YAG laser treatment was well-tolerated, with 83% of patients reporting low pain levels and high satisfaction, making it a safe and effective outpatient option for managing bladder cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium:YAG laser treatment of recurrent superficial bladder carcinoma: initial clinical experience. Syed, HA., Biyani, CS., Bryan, N., et al.[2016]

In a study of 82 patients undergoing surgery for benign prostatic hyperplasia, the MOSESTM technology showed significantly shorter operative times compared to the thulium fiber laser (TFL), indicating a more efficient surgical option.

Both MOSESTM and TFL demonstrated comparable safety and postoperative outcomes, such as urinary function and complication rates, suggesting that MOSESTM is an effective alternative for treating BPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative analysis of MOSESTM technology versus novel thulium fiber laser (TFL) for transurethral enucleation of the prostate: A single-institutional study. Elmansy, H., Hodhod, A., Elshafei, A., et al.[2022]

The Lumenis® High-power Holmium Laser with Moses technology showed promising stone fragmentation capabilities, achieving a rate of 95.8 mm3/min compared to 58.1 mm3/min without the technology, although this difference was not statistically significant.

Surgeons rated the Moses technology as better or much better in 17 out of 23 procedures, indicating a positive perception of its effectiveness in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Clinical Experience with a Modulated Holmium Laser Pulse-Moses Technology: Does It Enhance Laser Lithotripsy Efficacy? Mullerad, M., Aguinaga, JRA., Aro, T., et al.[2020]

In an in vitro study comparing Lumenis Moses Technology and Quanta's Vapor Tunnel, the Moses Distance (MD) mode showed superior stone ablation efficiency at shorter distances (0.5 mm) and comparable performance at longer distances (2 mm) for trough testing.

The Vapor Tunnel (VT) mode excelled in single crater testing at a distance of 2 mm, indicating that different pulse modulation technologies can significantly affect laser lithotripsy outcomes depending on the specific parameters used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Different Pulse Modulation Modes for Holmium:Yttrium-Aluminum-Garnet Laser Lithotripsy Ablation in a Benchtop Model. Terry, RS., Ho, DS., Scialabba, DM., et al.[2023]

Thulium fiber laser (TFL) is a safe and effective method for the conservative treatment of upper urinary tract urothelial carcinoma (UTUC), with no intraoperative complications reported in a study of 28 patients.

In the short-term follow-up, TFL achieved optimal tumor ablation, with 70.4% of patients showing no tumor at the second biopsy and a recurrence rate of 21.7% at 6 months, indicating promising outcomes for this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Thulium Fiber Laser in the Conservative Management of Patients with Upper Tract Urothelial Carcinoma. Proietti, S., Johnston, T., Pupulin, M., et al.[2022]

References

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

Clinical Impact of the Institution of Moses Technology on Efficiency During Retrograde Ureteroscopy for Stone Disease: Single-Center Experience. [2022]

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

Which Laser System Is Optimal for Cystolithotripsy of Large Bladder Calculi? [2023]

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

Holmium:YAG laser treatment of recurrent superficial bladder carcinoma: initial clinical experience. [2016]

4. Italy pubmed.ncbi.nlm.nih.gov

Comparative analysis of MOSESTM technology versus novel thulium fiber laser (TFL) for transurethral enucleation of the prostate: A single-institutional study. [2022]

5. Israel pubmed.ncbi.nlm.nih.gov

Initial Clinical Experience with a Modulated Holmium Laser Pulse-Moses Technology: Does It Enhance Laser Lithotripsy Efficacy? [2020]

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

Comparison of Different Pulse Modulation Modes for Holmium:Yttrium-Aluminum-Garnet Laser Lithotripsy Ablation in a Benchtop Model. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Thulium Fiber Laser in the Conservative Management of Patients with Upper Tract Urothelial Carcinoma. [2022]