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

124 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine if use of Moses 2.0 results in improved ablation efficiency during holmium laser vaporization of the prostate. To determine if use of Moses 2.0 results in less char, improved visibility, and improved hemostasis in prostate vaporization.

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 data supports the effectiveness of the Moses 2.0 Laser Treatment for Enlarged Prostate?

Research shows that the MOSES technology improves the efficiency and short-term outcomes of holmium laser ablation of the prostate, and it enhances energy delivery, potentially reducing operative times. Studies also indicate that holmium laser treatments, including those using MOSES technology, are effective and safe for treating benign prostatic hyperplasia (BPH), a condition characterized by an enlarged prostate. ^{1 2 3 4 5}

Is the Moses 2.0 Laser Treatment for Enlarged Prostate safe?

Research indicates that the Moses 2.0 laser technology is safe for treating benign prostate hyperplasia, with low rates of complications and the possibility of same-day discharge after the procedure. ^{1 2 3 6 7}

How is the Moses 2.0 Laser Treatment for Enlarged Prostate different from other treatments?

The Moses 2.0 Laser Treatment for Enlarged Prostate uses a special laser technology that improves energy delivery, making the procedure more efficient and potentially reducing the time needed for surgery compared to traditional laser treatments. ^{1 2 3 8 9}

Research Team

Donald Neff, MD

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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) 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]

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 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]

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]

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]

References

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

Utilization of MOSES Modulated Pulse Mode Results in Improved Efficiency in Holmium:YAG Laser Ablation of the Prostate. [2023]

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

MOSESTM Technology for Holmium Laser Enucleation of the Prostate: A Prospective Double-Blind Randomized Controlled Trial. [2021]

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

Efficiency and clinical outcomes of Moses technology for holmium laser enucleation of the prostate: An evidence-based analysis. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Holmium laser for the surgical treatment of benign prostatic hyperplasia. [2019]

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

Holmium laser for benign prostatic hyperplasia. [2007]

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

Holmium laser resection of the prostate: preliminary results of a new method for the treatment of benign prostatic hyperplasia. [2022]

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

Comparison of Newly Optimized Moses Technology vs Standard Holmium:YAG for Endoscopic Laser Enucleation of the Prostate. [2021]

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

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

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

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