Benign Prostatic HyperplasiaMoses 2NCT04979143
Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient
A study testing Surgical Approach in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
- What is being tested?
- Surgical Approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2022to 7 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- Patients with bothersome lower urinary tract symptoms who opt for surgical management
- Prostate size 60g or less
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66104
About this study
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.
Read the detailed description
Patients will be evaluated preoperatively per standard of care in urology clinic. We will obtain American Urological Association Symptom Score (AUA-SS) and Quality of Life (QoL) assessment as well as post-void residual bladder scan (PVR), and prostate specific antigen (PSA). All of these assessments will be part of standard of care.
Based on the current coronavirus (COVID-19) pandemic and the changing health landscape with increased emphasis on telehealth, patient may be offered virtual appointments for aspects of the trial that do not require in-person evaluation or testing. These include but are not limited to inclusion/exclusion criteria evaluation, consent for trial participation, or survey completion.
Patients will be taken to the operating room per standard of care. They will be randomized to either Holmium Laser Vaporization of Prostate (HoLVP) with or without the use of Moses 2.0 technology. The surgeon and patient will both be blinded to the laser mode.
HoLVP will occur in standard fashion thereafter utilizing at 550-micron holmium Xpeeda side fire laser fiber at settings of 2 Joules, 50 Hertz. Moses 2.0 will be activated or not by operating room personnel based on patient's randomization status. Again, the surgeon and assistant will not be informed of the Moses status.
Intraoperative parameters will be recorded including total procedure time, total vaporization time, vaporization efficiency (g/min), and total energy used. Surgeons will evaluate tissue char, visibility, hemostasis, as well as select if they think Moses 2.0 was activated or not for the procedure.
Timeline for catheter removal will be per surgeon discretion with a general plan for removal in the post-anesthesia care unit with trial of void before discharge on day of surgery. If patient is discharged with a catheter in place, removal date will be determined per surgeon's discretion.
Patients will be seen in urology clinic for follow up per standard of care at 6 weeks, 3 months, and 12 months post operatively at which time we will obtain symptom questionnaires. A PVR will be obtained at 6 weeks. PSA will be measured at 3 months post operatively, to act as a surrogate marker for percentage of tissue vaporized since it can be compared to pre-operative PSA.
Outcomes from surgery will be assessed including changing in AUA-SS and QoL, and PVR. We will also evaluate for complications such as urethral stricture, bladder neck contracture, and need for re-operation.
- Being tested
- Surgical Approach
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical ApproachProcedure or surgery
The surgical laser used will be randomized. All lasers used during this trial are all FDA approved devices and used per routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| HoLVP with the use of Moses 2.0 technology | Other | HoLVP with the use of Moses 2.0 technology Receives: Procedure: Surgical Approach |
| HoLVP without the use of Moses 2.0 technology | Other | HoLVP without the use of Moses 2.0 technology Receives: Procedure: Surgical Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Tissue char, visibility, and hemostasis will be evaluated by the surgeon performing the procedure and ranked on a 10-point scale. For these outcomes, we do not have as much preliminary data, however, it is reasonable to assume a moderate effect size, as was observed in a study of Holmium Laser Enucleation of Prostate (HoLEP) We will test for differences in the secondary outcomes using a multivariate ANOVA. The sample size for the primary outcome will provide greater than 80% power for this test, using the O'Brien and Shieh algorithm.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start28 Nov 2022
- Primary completion12 May 2025
- Study completion7 Jul 2025
Why it stopped: Slow recruitment due to new alternative surgical treatment options emerging and being requested by patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Don Neff, MD, FACS, University of Kansas Medical Center
- Investigators
- Donald Neff, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979143
- Sponsor's protocol ID
- GU-EN-MOSES 2.0
- Acronym
- Moses 2
- Status last verified
- Aug 2025
- First submitted
- 16 Jul 2021
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moses Vaporization: Is Use of Moses 2.0 in Holmium Laser Ablation of the Prostate More Efficient
- ClinicalTrials.gov ID
- NCT04979143
- Acronym / sponsor ID
- Moses 2 / GU-EN-MOSES 2.0
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment due to new alternative surgical treatment options emerging and being requested by patients.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 7 Jul 2025 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be evaluated preoperatively per standard of care in urology clinic. We will obtain American Urological Association Symptom Score (AUA-SS) and Quality of Life (QoL) assessment as well as post-void residual bladder scan (PVR), and prostate specific antigen (PSA). All of these assessments will be part of standard of care.
Based on the current coronavirus (COVID-19) pandemic and the changing health landscape with increased emphasis on telehealth, patient may be offered virtual appointments for aspects of the trial that do not require in-person evaluation or testing. These include but are not limited to inclusion/exclusion criteria evaluation, consent for trial participation, or survey completion.
Patients will be taken to the operating room per standard of care. They will be randomized to either Holmium Laser Vaporization of Prostate (HoLVP) with or without the use of Moses 2.0 technology. The surgeon and patient will both be blinded to the laser mode.
HoLVP will occur in standard fashion thereafter utilizing at 550-micron holmium Xpeeda side fire laser fiber at settings of 2 Joules, 50 Hertz. Moses 2.0 will be activated or not by operating room personnel based on patient's randomization status. Again, the surgeon and assistant will not be informed of the Moses status.
Intraoperative parameters will be recorded including total procedure time, total vaporization time, vaporization efficiency (g/min), and total energy used. Surgeons will evaluate tissue char, visibility, hemostasis, as well as select if they think Moses 2.0 was activated or not for the procedure.
Timeline for catheter removal will be per surgeon discretion with a general plan for removal in the post-anesthesia care unit with trial of void before discharge on day of surgery. If patient is discharged with a catheter in place, removal date will be determined per surgeon's discretion.
Patients will be seen in urology clinic for follow up per standard of care at 6 weeks, 3 months, and 12 months post operatively at which time we will obtain symptom questionnaires. A PVR will be obtained at 6 weeks. PSA will be measured at 3 months post operatively, to act as a surrogate marker for percentage of tissue vaporized since it can be compared to pre-operative PSA.
Outcomes from surgery will be assessed including changing in AUA-SS and QoL, and PVR. We will also evaluate for complications such as urethral stricture, bladder neck contracture, and need for re-operation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HoLVP with the use of Moses 2.0 technology | Other | Procedure: Surgical ApproachHoLVP with the use of Moses 2.0 technology |
| HoLVP without the use of Moses 2.0 technology | Other | Procedure: Surgical ApproachHoLVP without the use of Moses 2.0 technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Patients with bothersome lower urinary tract symptoms who opt for surgical management
- Prostate size 60g or less
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical ApproachThe surgical laser used will be randomized. All lasers used during this trial are all FDA approved devices and used per routine clinical care. | Procedure or surgery | HoLVP with the use of Moses 2.0 technology, HoLVP without the use of Moses 2.0 technology |
Primary outcome
The primary outcome is vaporization efficiency, measured in g/min
Time frame: 5 years
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.
1 secondary outcome
Tissue char, visibility, and hemostasis will be evaluated by the surgeon performing the procedure and ranked on a 10-point scale
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Slow recruitment due to new alternative surgical treatment options emerging and being requested by patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Benign Prostatic Hyperplasia
Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Neff principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Approach in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment due to new alternative surgical treatment options emerging and being requested by patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is vaporization efficiency, measured in g/min (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.