Benign Prostatic HyperplasiaPhase 3NCT04263987
A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
A Phase 3 study testing Moses laser enucleation of prostate in people with Benign Prostatic Hyperplasia, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses Pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. Read more about this study
- Who is it for?
- Ages 50 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Moses laser enucleation of prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 30 Dec 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at greater than 80 grams
Who cannot join
- Anyone actively on anticoagulation perioperatively
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses Pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. We seek to evaluate Moses technology for enucleation of the prostate in the setting of BPH.
Read the detailed description
This is a single-center, prospective, double-blinded, randomized controlled trial comparing MOLEP to HOLEP. Inclusion criteria included all symptomatic BPH patients desiring enucleation with prostate sizes > 80ccs based on cross-sectional imaging. Patients are randomized in a 1:1 fashion and the study is powered to evaluate for a difference in operative time (i.e. alpha=0.05,N=21 per group). All surgeries will be performed with a 550 μm fiber. At the start of each case, a laser technician would be notified of randomization via envelope and randomize the settings to either Moses or traditional mode. The surgeons and patients were blinded to which mode was used. All surgeries will be performed using a two lobe technique and laser settings between 2J and 20-40Hz. Further recorded endpoints include change in blood loss, reduction in International Prostate Symptom Score (IPSS), improvement in uroflow parameters, and complications postoperatively at 6 weeks.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Moses laser enucleation of prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moses laser enucleation of prostateProcedure or surgery
Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time
| Study group | Role | What they receive |
|---|---|---|
| Holmium Laser Enucleation of Prostate | Active comparator | Traditional holmium laser enucleation of the prostate as currently performed Receives: Procedure: Moses laser enucleation of prostate |
| Moses Holmium Laser Enucleation of Prostate | Experimental | holmium laser enucleation of the prostate as currently performed but with Moses laser settings activated. Receives: Procedure: Moses laser enucleation of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Time
time for surgery to take place
Measured: intraoperatively
Secondary outcomes (1)
Percentage of Change of Hematocrit
Blood loss is calculated by the percentage of change of hematocrit
Measured: Baseline to postoperatively day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2020
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicholas Kavoussi, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263987
- Sponsor's protocol ID
- MOLEP Study
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2020
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial
- ClinicalTrials.gov ID
- NCT04263987
- Acronym / sponsor ID
- MOLEP Study
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Posted 31 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Holmium laser enucleation of the prostate (HOLEP) has proven to be efficacious and safe for the treatment of benign prostatic hypertrophy (BPH). New laser technologies such as the Moses Pulse laser system provide for improved energy delivery which may decrease blood loss and operative time. We seek to evaluate Moses technology for enucleation of the prostate in the setting of BPH.
Detailed description
This is a single-center, prospective, double-blinded, randomized controlled trial comparing MOLEP to HOLEP. Inclusion criteria included all symptomatic BPH patients desiring enucleation with prostate sizes > 80ccs based on cross-sectional imaging. Patients are randomized in a 1:1 fashion and the study is powered to evaluate for a difference in operative time (i.e. alpha=0.05,N=21 per group). All surgeries will be performed with a 550 μm fiber. At the start of each case, a laser technician would be notified of randomization via envelope and randomize the settings to either Moses or traditional mode. The surgeons and patients were blinded to which mode was used. All surgeries will be performed using a two lobe technique and laser settings between 2J and 20-40Hz. Further recorded endpoints include change in blood loss, reduction in International Prostate Symptom Score (IPSS), improvement in uroflow parameters, and complications postoperatively at 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Holmium Laser Enucleation of Prostate | Active comparator | Procedure: Moses laser enucleation of prostateTraditional holmium laser enucleation of the prostate as currently performed |
| Moses Holmium Laser Enucleation of Prostate | Experimental | Procedure: Moses laser enucleation of prostateholmium laser enucleation of the prostate as currently performed but with Moses laser settings activated. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any man with clinical symptoms fo BPH requiring surgery who has a prostate sized at greater than 80 grams
Key exclusion criteria (1 listed)
- Anyone actively on anticoagulation perioperatively
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 |
|---|---|---|
| Moses laser enucleation of prostateUsing the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time | Procedure or surgery | Holmium Laser Enucleation of Prostate, Moses Holmium Laser Enucleation of Prostate |
Primary outcome
Operative Time
Time frame: intraoperatively
time for surgery to take place
1 secondary outcome
Percentage of Change of Hematocrit
Time frame: Baseline to postoperatively day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moses laser enucleation of prostate in people with Benign Prostatic Hyperplasia, run by Vanderbilt University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Mar 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Operative Time (time frame: intraoperatively). 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 31 Mar 2022.