Moses 2.0 Laser Treatment for Enlarged Prostate

(Moses 2 Trial)

Overseen By Jane Ledesma

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Prostate cancer, Neurogenic bladder, 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: 7

Duration: 1 day

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new laser technology called Moses 2.0 to determine if it can make surgery for an enlarged prostate more effective. The researchers aim to find out if this laser treatment improves the removal of prostate tissue, reduces charring, and provides better visibility during surgery. Participants will receive the laser treatment either with or without the Moses 2.0 technology. Men experiencing bothersome urinary symptoms and considering surgery, with a prostate size of 60 grams or less, might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

If you are taking anticoagulation or antiplatelet medications, you will need to stop them to participate in this trial. However, if you are taking Aspirin 81, you can continue using it during the study.

What prior data suggests that the Moses 2.0 technology is safe for prostate vaporization?

Research has shown that the Moses 2.0 technology used in holmium laser treatments is safe for patients. One study found that this technology not only speeds up the procedure but also enhances safety by reducing the time needed for certain surgical steps. Another study confirmed that treatments using Moses 2.0 are effective and safe for prostate issues, making it a reliable choice for these procedures.

Specifically, individuals treated with Moses 2.0 experienced positive outcomes. The technology is well-tolerated, and studies reported no major safety concerns. This could be a suitable option for those considering a clinical trial for prostate treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Moses 2.0 Laser Treatment for enlarged prostate because it offers a potentially more precise and efficient approach compared to traditional methods like transurethral resection of the prostate (TURP) or standard Holmium Laser Vaporization of the Prostate (HoLVP). The Moses 2.0 technology enhances laser energy delivery, enabling better vaporization of prostate tissue with less thermal damage to surrounding areas. This could mean a quicker recovery and fewer side effects for patients. Additionally, it may improve outcomes in terms of reducing urinary symptoms and improving quality of life more effectively than existing treatments.

What evidence suggests that the Moses 2.0 technology is effective for improving prostate vaporization?

This trial will compare Holmium Laser Vaporization of the Prostate (HoLVP) with and without Moses 2.0 technology. Studies have shown that Moses 2.0 technology enhances the efficiency of holmium laser treatment for an enlarged prostate. Specifically, patients experienced faster treatment times, making the procedure quicker. Research also indicates that Moses 2.0 improves visibility during the procedure and better controls bleeding. This technology allows some patients to go home the same day due to faster recovery. Overall, Moses 2.0 appears to provide a more efficient and effective treatment for an enlarged prostate compared to the standard method. ^{1 3 5 6 7}

Who Is on the Research Team?

Donald Neff, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

This trial is for men over 18 with bothersome urinary symptoms due to an enlarged prostate (60g or less), who choose surgery. It's not suitable for those outside this group.

Inclusion Criteria

I am choosing surgery to manage my severe urinary symptoms.

My prostate is 60g or smaller.

I am older than 18 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Preoperative Evaluation

Preoperative assessments including AUA-SS, QoL, PVR, and PSA are conducted as part of standard care

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo Holmium Laser Vaporization of the Prostate (HoLVP) with or without Moses 2.0 technology

1 day

1 visit (in-person)

Immediate Postoperative Care

Catheter removal and trial of void before discharge; discharge with catheter if necessary

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness at 6 weeks, 3 months, and 12 months postoperatively

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Holmium Laser Vaporization of the Prostate with Moses 2.0

Trial Overview The study tests if Moses 2.0 technology improves the efficiency, visibility, and blood control during laser vaporization of the prostate compared to standard methods.

How Is the Trial Designed?

Group I: HoLVP without the use of Moses 2.0 technology Experimental Treatment 1 Intervention

HoLVP without the use of Moses 2.0 technology

Group II: HoLVP with the use of Moses 2.0 technology Experimental Treatment 1 Intervention

HoLVP with the use of Moses 2.0 technology

Holmium Laser Vaporization of the Prostate with Moses 2.0 is already approved in United States, European Union for the following indications:

Approved in United States as Holmium Laser Vaporization of the Prostate with MOSES 2.0 for:

• Benign Prostatic Hyperplasia (BPH)

Approved in European Union as Holmium Laser Vaporization of the Prostate with MOSES 2.0 for:

• Benign Prostatic Hyperplasia (BPH)

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Published Research Related to This Trial

Moses laser enucleation of the prostate (MoLEP) demonstrated significant advantages over holmium laser enucleation of the prostate (HoLEP) in terms of shorter hemostasis, enucleation, and operative times, as well as reduced intraoperative blood loss and hospital stay, based on a meta-analysis of 12 studies involving 1160 patients.

MoLEP also resulted in a lower total postoperative complications rate compared to HoLEP, although both procedures showed similar outcomes in terms of symptom relief and urinary function, indicating MoLEP may be a safer and more efficient option for treating benign prostatic hyperplasia (BPH).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency and clinical outcomes of Moses technology for holmium laser enucleation of the prostate: An evidence-based analysis. Li, K., Meng, C., Li, J., et al.[2023]

Holmium laser ablation of the prostate (HoLAP) is an effective treatment for patients with large prostate glands, significantly reducing prostate volume by 55% and improving urinary symptoms by 70% in a study of 17 patients.

The procedure is safe, with no cases of postoperative stress incontinence, minimal blood loss, and a short hospital stay, making it a favorable alternative to open prostatectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid communication: holmium laser ablation of large prostate glands: an endourologic alternative to open prostatectomy. Kumar, SM.[2016]

Recent advancements in laser technologies, particularly Ho:YAG with Moses technology and Thulium Fiber Laser (TFL), have shown to be efficient and safe for treating benign prostatic hyperplasia (BPH), comparable to standard Ho:YAG laser techniques.

In vitro studies on blue diode and hybrid lasers indicate promising incision depths and coagulation properties, but more research is needed to evaluate their effectiveness and safety in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lasers for benign prostatic hyperplasia (hybrid, blue diode, TFL, Moses). Which one to choose? Doizi, S.[2022]

The use of MOSES technology in holmium laser ablation of the prostate (HoLAP) significantly improved ablation efficiency, with a rate of 0.86 g/min compared to 0.59 g/min without MOSES, indicating a more effective procedure.

Despite the increased efficiency with MOSES, postoperative outcomes such as symptom scores, quality of life, and complications were similar between the two groups, suggesting that MOSES enhances procedural efficiency without compromising patient safety or short-term results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of MOSES Modulated Pulse Mode Results in Improved Efficiency in Holmium:YAG Laser Ablation of the Prostate. Whiles, BB., Martin, AJ., Brevik, A., et al.[2023]

Holmium laser enucleation of the prostate is a safe and effective surgical technique for treating benign prostatic hyperplasia, suitable for patients with various conditions, including those on anticoagulants and those experiencing urinary retention.

Despite its effectiveness and lower morbidity compared to traditional methods, the holmium laser technique has not been widely adopted due to a prolonged learning curve for surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser for benign prostatic hyperplasia. Seki, N., Naito, S.[2007]

Holmium laser ablation of the prostate (HoLAP) and holmium laser enucleation of the prostate (HoLEP) both provide effective surgical options for treating benign prostatic hyperplasia (BPH), with similar outcomes over a follow-up period of up to 38 months.

The study, which analyzed 169 men, found no significant difference in urinary flow rate improvements between HoLAP and HoLEP, suggesting that when performed correctly, HoLAP can be as effective as HoLEP for managing BPH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser for the surgical treatment of benign prostatic hyperplasia. Thurmond, P., Bose, S., Lerner, LB.[2019]

In a study of 60 patients, holmium laser enucleation of the prostate using MOSES technology significantly reduced total operative time (101 minutes vs. 126 minutes) and enucleation times compared to traditional methods, indicating improved efficiency in the procedure.

The MOSES technology also resulted in less blood loss and shorter hemostasis times, while maintaining similar functional outcomes and safety profiles compared to traditional holmium laser enucleation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MOSESTM Technology for Holmium Laser Enucleation of the Prostate: A Prospective Double-Blind Randomized Controlled Trial. Kavoussi, NL., Nimmagadda, N., Robles, J., et al.[2021]

Holmium laser resection of the prostate (HoLRP) significantly improves symptoms of benign prostatic hyperplasia (BPH), with the average AUA symptom score dropping from 21.3 preoperatively to 4.1 at 3 months after surgery, indicating effective symptom relief.

The procedure is safe, with only 2% of patients experiencing heavy bleeding requiring irrigation and 5% needing recatheterization, while most patients reported minimal irritative urinary symptoms postoperatively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Holmium laser resection of the prostate: preliminary results of a new method for the treatment of benign prostatic hyperplasia. Gilling, PJ., Cass, CB., Cresswell, MD., et al.[2022]

The newly optimized Moses technology for holmium laser enucleation of the prostate (M2-HoLEP) demonstrated faster hemostasis times and rates compared to standard holmium:YAG technology (S-HoLEP), indicating improved surgical efficiency.

M2-HoLEP allowed for same-day discharge in 69.4% of patients, while maintaining low rates of complications and similar postoperative outcomes for urinary symptoms and erectile dysfunction compared to S-HoLEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Newly Optimized Moses Technology vs Standard Holmium:YAG for Endoscopic Laser Enucleation of the Prostate. Nottingham, CU., Large, T., Agarwal, DK., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04979143

Is Use of Moses 2.0 in Holmium Laser Ablation ... The primary outcome is vaporization efficiency, measured in g/min. For the purposes of this study, we defined improvement as at least a 50% improvement in ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33025749/

Holmium laser enucleation of the prostate using Moses 2.0 ... Conclusion: Moses 2.0 has higher enucleation efficiency compared to non-Moses when used by experts. The subjective evaluation favoured Moses 2.0. Keywords: # ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2405456922000360

Does MOSES Technology Enhance the Efficiency and ... We found that the MOSES laser system can improve intraoperative performance, making prostate treatment a same-day discharge surgery.

4. bostonscientific.com bostonscientific.com/en-US/medical-specialties/urology/laser-therapies/moses-technology/prostate-enucleation-and-vaporization.html

Benign Prostate Hyperplasia (BPH) - Lumenis Pulse™ Surgeons new to enucleation demonstrated 44% higher procedural efficiency using MOSES 2.0 Technology compared to standard holmium laser ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9486436/

Comparative efficacy and safety of holmium laser ... Moses HoLEP demonstrated shorter enucleation time, shorter hemostasis time and shorter laser use time. Moses HoLEP also possessed lower PVR.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2049080122010408

Comparative efficacy and safety of holmium laser ... The results of this study suggested that Moses HoLEP significantly shorten the enucleation time, hemostasis time, and laser use time in intraoperative procedure ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39412530/

Second-generation MOSES 2.0 versus MOSES 1.0 pulse- ... Conclusions: HoLEP with second-generation MOSES 2.0 technology is a safe and effective treatment option for BPH. It offers notable improvements, ...