Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient

NCT04979143 | Terminated

• 1 other identifier: GU-EN-MOSES 2.0
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

• The primary outcome is vaporization efficiency, measured in g/min

  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 ablation efficiency, based on improvements in enucleation efficiency observed in a recent study . Furthermore, based on a previous study we made of Moses 1.0, the ablation efficiency of Moses 1.0 is 1.77 g/min with a standard deviation of 1.41 g/min.7 Differences in ablation efficiency will be tested via Welch's t-test.10 Therefore, we calculated the sample size based on an anticipated improvement of efficiency to at least 2.66 g/min. We further allowed for a somewhat higher standard deviation for Moses 2.0 at 2 g/min, as the variance tends to increase as the efficiency increases. This resulted in an anticipated standardized effect size of approximately 0.51 standard deviations (moderate effect). At a significance level of 0.05 and 80% power, this means we will need 62 subjects per arm in the study.

  5 years

Secondary Outcomes (1)

• Tissue char, visibility, and hemostasis will be evaluated by the surgeon performing the procedure and ranked on a 10-point scale

  5 years

Study Arms (2)

HoLVP with the use of Moses 2.0 technology

OTHER

HoLVP with the use of Moses 2.0 technology

Procedure: Surgical Approach

HoLVP without the use of Moses 2.0 technology

OTHER

HoLVP without the use of Moses 2.0 technology

Procedure: Surgical Approach

Interventions

Surgical Approach PROCEDURE

The surgical laser used will be randomized. All lasers used during this trial are all FDA approved devices and used per routine clinical care.

HoLVP with the use of Moses 2.0 technology; HoLVP without the use of Moses 2.0 technology

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Males only. Study is looking at benign prostate hyperplasia and lower urinary tract symptoms. Females do not have prostates
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years of age
• Patients with bothersome lower urinary tract symptoms who opt for surgical management
• Prostate size 60g or less

You may not qualify if:

• Current use of anticoagulation or antiplatelet agent Aspirin 81 use is okay and can be continued through the study
• Bleeding diathesis
• AUA symptom score \< 9
• Current urinary retention
• Known diagnosis of prostate cancer
• Known diagnosis of neurogenic bladder

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66104, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donald Neff

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 28, 2021
• Study Start: November 28, 2022
• Primary Completion: May 12, 2025
• Study Completion: July 7, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)