Benign Prostatic Hyperplasia (BPH)NCT04648176
Application of MOSES Technology in BPH
A study testing Moses technology in people with Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms
- What is being tested?
- Moses technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 6 Mar 2020to 30 Jun 2023
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prostatic volume between 70-200cc
- Acceptance to participate in the study.
Who cannot join
- Previous urethra stricture
- Previous prostate surgery
- Neurogenic bladder
- Bladder tumor
- Neurological disease with repercussion in the lower urinary tract.
- Severe psychiatric illness
- Inability of the patient to consent
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
Adrià Piñero, MD
Jose Placer Santos, PhD
About this study
Official title: Evaluation of Surgical and Functional Results of the Application of MOSES Technology in the Holmium Laser Prostate Enucleation as a Treatment for Tract Symptoms Lower Urinary Secondary to Benign Prostatic Hyperplasia
In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.
Read the detailed description
In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation using MOSES technology.
- Being tested
- Moses technology
- Keywords
- laser, Holmium, HoLEP, Moses
- 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.
Moses technologyDevice
Using Holmium laser with Moses technology or conventional one
| Study group | Role | What they receive |
|---|---|---|
| HoLEP | Active comparator | Conventional laser Receives: Device: Moses technology |
| m-HoLEP | Experimental | Moses technology Receives: Device: Moses technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Hemoglobin change
Measured: 24 hours after the surgery
Secondary outcomes (9)
Enucleation time
Enucleation time change
Measured: during the surgery
Hemostasis time
Hemostasis time change
Measured: during the surgery
Morcellating time
Morcellating time change
Measured: during the surgery
Surgery time
Surgery time change
Measured: during the surgery
Irrigated volume of serum
Irrigated volume of serum change
Measured: during the surgery
complication rate
difference of complication rate
Measured: one month after the surgery
urinary tract infection
urinary tract infection rate differences
Measured: one month after the surgery
lower urinary tract symptoms
lower urinary tract symptoms rate differences
Measured: through study completion, an average of 3 years
sexual function
sexual function differences
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start6 Mar 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Placer Santos, PhD, Principal investigator, Vall d'Hebrón University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648176
- Sponsor's protocol ID
- PR(AG)501/2019
- Status last verified
- Nov 2020
- First submitted
- 6 Mar 2020
- Last updated
- 1 Dec 2020
- Results posted
- 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 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgical and Functional Results of the Application of MOSES Technology in the Holmium Laser Prostate Enucleation as a Treatment for Tract Symptoms Lower Urinary Secondary to Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT04648176
- Acronym / sponsor ID
- PR(AG)501/2019
- Keywords
- laser, Holmium, HoLEP, Moses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 1 Dec 2020 (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.
In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation.
Detailed description
In this study the investigators intend to compare the surgical and functional results of two different modalities of the use of the Holmium laser in prostate enucleation using MOSES technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HoLEP | Active comparator | Device: Moses technologyConventional laser |
| m-HoLEP | Experimental | Device: Moses technologyMoses technology |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prostatic volume between 70-200cc
- Acceptance to participate in the study.
Key exclusion criteria (7 listed)
- Previous urethra stricture
- Previous prostate surgery
- Neurogenic bladder
- Bladder tumor
- Neurological disease with repercussion in the lower urinary tract.
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 technologyUsing Holmium laser with Moses technology or conventional one | Device | HoLEP, m-HoLEP |
Primary outcome
Hemoglobin
Time frame: 24 hours after the surgery
Hemoglobin change
9 secondary outcomes
Enucleation time
Time frame: during the surgery
Hemostasis time
Time frame: during the surgery
Morcellating time
Time frame: during the surgery
Surgery time
Time frame: during the surgery
Irrigated volume of serum
Time frame: during the surgery
complication rate
Time frame: one month after the surgery
urinary tract infection
Time frame: one month after the surgery
lower urinary tract symptoms
Time frame: through study completion, an average of 3 years
sexual function
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- 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.
José Placer Santos, PhD principal investigator
Vall d'Hebrón University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moses technology in people with Benign Prostatic Hyperplasia (BPH) and Lower Urinary Tract Symptoms, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Dec 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrià Piñero Zomeño, MD (934893000 ext. 6370, adria.pinero@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: 24 hours after the surgery). 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 1 Dec 2020; AzTrials last refreshed its copy on 29 Oct 2026.