Benign Prostatic HyperplasiaNCT06965582
A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System
A study testing ALPFA BPH PFA System in people with Benign Prostatic Hyperplasia, run by ALPFA Medical at 4 sites in 3 countries.
Trial summary
The ALPFA Medical BPH Pilot Study is a prospective, open label, single arm pilot study to assess the use of the ALPFA BPH PFA System in the treatment of men over the age of 45 with obstructive urinary symptoms associated with BPH. Male subjects will be consented and undergo protocol-defined baseline assessments. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- ALPFA BPH PFA System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Feb 2025to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are ≥ 45 years of age on the day of enrollment.
- Patients who have failed to achieve satisfactory resolution of BPH symptoms using an approved medication.
- Life expectancy: the patient has a life expectancy of ≥ 1 year
- Patient participation: The patient
- is free of physical, psychological or other impairment that would prevent their ability to understand and comply with all study requirements.
- is willing and capable of providing Informed Consent to undergo study procedures.
- agrees to fully participate in all examinations, study requirements, follow-up visits and tests associated with this clinical study.
- lives close enough to the investigational site to facilitate the required in-person visits.
Who cannot join
- Urologic conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
- Previous operative intervention for BPH
- Active urinary tract infection (may be treated and enrolled upon negative urine culture).
- Prostatitis: a history of any prostatitis within 2 years of enrollment.
- Cystolithiasis active within 90 days of enrollment
- artificial sphincters.
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- Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer
- Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
- Unstable cardiovascular disease including: i. NYHA III/IV heart failure or LVEF < 40% ii. Uncontrolled arrhythmia iii. Stroke, TIA, thromboembolic event, myocardial infarction, unstable angina, percutaneous coronary intervention or any cardiac surgery within 90 days of enrollment iv. Uncontrolled hypertension b. Immunosuppression: Known immunosuppression, including but not limited to AIDS, immunosuppressive medication or current chemotherapy.
- Coagulopathy: Diagnosed disorder of blood clotting or bleeding diathesis. d. Transplant: History of any solid organ or hematologic transplant, or currently being evaluated for an organ transplant e. Active substance abuse: active alcoholism or
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
About this study
Official title: A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System In Men With Symptomatic Benign Prostatic Hyperplasia
The ALPFA Medical BPH Pilot Study is a prospective, open label, single arm pilot study to assess the use of the ALPFA BPH PFA System in the treatment of men over the age of 45 with obstructive urinary symptoms associated with BPH.
Male subjects will be consented and undergo protocol-defined baseline assessments. Those who meet study entry criteria will be enrolled and treated with the ALPFA BPH PFA System and then undergo follow-up with protocol-defined assessment.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- ALPFA BPH PFA System
- Keywords
- prostate, BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALPFA BPH PFA SystemDevice
PFA system for treatment of Benign Prostatic Hyperplasia
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Device: ALPFA BPH PFA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Outcome
The safety endpoint for this study is a Composite Safety Endpoint (CSE) defined as the proportion of subjects with one or more device- or procedure-related serious adverse events (SAEs) through 30 days post-procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start7 Feb 2025
- Primary completionMar 2030 (estimated)
- Study completionMar 2030 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALPFA Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965582
- Sponsor's protocol ID
- CS-00001
- Status last verified
- Jun 2026
- First submitted
- 27 Apr 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Of The ALPFA Benign Prostatic Hyperplasia (BPH) Pulsed Field Ablation (PFA) System In Men With Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT06965582
- Acronym / sponsor ID
- CS-00001
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- prostate, BPH
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- ALPFA MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 11 May 2025 (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.
The ALPFA Medical BPH Pilot Study is a prospective, open label, single arm pilot study to assess the use of the ALPFA BPH PFA System in the treatment of men over the age of 45 with obstructive urinary symptoms associated with BPH.
Male subjects will be consented and undergo protocol-defined baseline assessments. Those who meet study entry criteria will be enrolled and treated with the ALPFA BPH PFA System and then undergo follow-up with protocol-defined assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: ALPFA BPH PFA System |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients who are ≥ 45 years of age on the day of enrollment.
- Patients who have failed to achieve satisfactory resolution of BPH symptoms using an approved medication.
- Life expectancy: the patient has a life expectancy of ≥ 1 year
- Patient participation: The patient
Key exclusion criteria (10 listed)
- Urologic conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
- Bladder cancer: a history of treated bladder cancer of Stage T2 or higher, or a clinical suspicion of bladder cancer
- Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or confound data or its interpretation, including but not limited to:
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 |
|---|---|---|
| ALPFA BPH PFA SystemPFA system for treatment of Benign Prostatic Hyperplasia | Device | Treatment Arm |
Primary outcome
Primary Safety Outcome
Time frame: 30 days
The safety endpoint for this study is a Composite Safety Endpoint (CSE) defined as the proportion of subjects with one or more device- or procedure-related serious adverse events (SAEs) through 30 days post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ALPFA BPH PFA System in people with Benign Prostatic Hyperplasia, run by ALPFA Medical at 4 sites in 3 countries.
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 8 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, Italy, Panama. 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary Safety Outcome (time frame: 30 days). 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 25 Jun 2026.