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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine differences in outcomes when using two types of lasers, the MOSES Holmium and the Thulium Fiber Laser (TFL), for removing bladder tumors. Participants will be randomly assigned to have their bladder tumor removed with either the MOSES or TFL laser. The trial is for individuals diagnosed with a bladder tumor after a scope test (cystoscopy) and deemed suitable for laser treatment. Those with a bladder tumor that is not too advanced may be eligible. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially benefit from innovative laser 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the Thulium Fiber Laser (TFL) is generally safe for treating bladder tumors. Research indicates that TFL leads to fewer side effects and effectively removes tumors, while also causing less bleeding during procedures.

For the MOSES Holmium Laser, research suggests it provides efficient treatment with shorter procedure times. This laser has demonstrated safety in other treatments, such as those for prostate issues, suggesting it is also safe for bladder tumor procedures.

Overall, both lasers appear well-tolerated, with past studies supporting their safety and effectiveness in similar medical procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer advanced laser technologies for bladder cancer surgery. The Thulium Fibre Laser (TFL) provides precise cutting with minimal bleeding, potentially reducing recovery time. Meanwhile, the MOSES Holmium Laser optimizes energy delivery, which may enhance surgical efficiency and reduce damage to surrounding tissues. These technologies could offer significant improvements over traditional methods, aiming for better outcomes and quicker recovery for patients.

What evidence suggests that this trial's treatments could be effective for bladder cancer?

This trial will compare the Thulium Fiber Laser (TFL) and the MOSES Holmium Laser for treating bladder tumors. Research has shown that both lasers are promising tools. Participants in the TFL arm will undergo bladder resection using the Thulium Fiber Laser. Studies indicate that this laser works well for tumors not larger than 3 cm, offering safe and efficient treatment with fewer side effects. Meanwhile, participants in the MOSES Holmium Laser arm will undergo bladder resection using this laser, which has been found to make tumor removal quicker and more efficient than traditional methods. Both lasers are considered safe and effective, having proven successful in treating similar conditions. ^{1 2 3 4 6}

Who Is on the Research Team?

Ahmed Z Ahmed

Principal Investigator

Thunder Bay Regional Health Sciences Centre

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0090429524001547

MOSES™ Technology vs Non-Moses Holmium Laser ... MoLEP demonstrated superior enucleation efficiency (3.5±0.8 g/min) and shorter enucleation time (22.5±7.6 minutes) compared to HoLEP, although not ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12004954/

A review of the Moses effect and its applications in ... The MOSES™ technology in lithotripsy showed promising preclinical results, and while clinical studies suggest potential benefits such as reduced retropulsion, ...

3. juniperpublishers.com juniperpublishers.com/jojun/pdf/JOJUN.MS.ID.555759.pdf

Holmium Laser En-bloc Resection of Bladder Tumor (HoL- ... control trial of Moses 2.0 vs non-Moses technology in patients undergoing holmium laser enucleation of prostate (HoLEP) and found that Moses ...

4. europeanurology.com europeanurology.com/issue/S0302-2838(24)X0003-2?pageStart=13

March 2024 Moses 2.0 Technology for holmium laser enucleation of the prostate ... bladder cancer – a secondary outcome analysis of the iROC trial.

5. cureus.com cureus.com/articles/378920-next-generation-moses-pulse-modulation-an-evaluation-of-whether-this-is-hype-or-breakthrough

Next-Generation Moses Pulse Modulation: An Evaluation ... Current literature evidence suggests Moses™ technology is associated with superior outcomes compared to standard holmium YAG laser in several ...

6. liebertpub.com liebertpub.com/doi/full/10.1089/end.2021.0531

Contemporary Outcomes for Patients Undergoing ... Background: Outcomes of holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia has been well studied.