Benign Prostatic HyperplasiaBPHNCT07745621
Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia
A study testing Minimally invasive percutaneous ablation in people with Benign Prostatic Hyperplasia, run by Vivifi Medical at 1 site in Panama.
Trial summary
The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Minimally invasive percutaneous ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePanama
- Study dates
- Sep 2026to Dec 2028
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male 45-80 years of age
- Diagnosed with Benign prostatic hyperplasia (BPH)
- Prostate volume: ≥ 40 ≤ 100 cc measured by MRI
- Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL)
- Assessment of future paternity plans
- Signed the study informed consent
- Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
Who cannot join
- Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.
- Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable
- Intravesical prostatic protrusion (IPP) > 10 mm
- Post-void residual volume (PVR) > 200ml
- IPSS QoL score ≤ 3
- Prostate cancer diagnosis, suspicious DRE, or PSA > 10ng/mL
Show all 14Show fewer
- Patients with clinical history of chronic prostatitis.
- Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures.
- Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury
- Patients who are unable to undergo the required anesthesia for the procedure
- Patients on testosterone replacement therapy
- Patients unable to hold blood thinners, or with coagulation related issues
- Patients currently taking medication for BPH (eg. Alpha-blockers or 5-ARIs) who are unwilling or unable to discontinue (washout) prior to treatment (14 days for α-blockers (tamsulosin, alfuzosin, silodosin, doxazosin, terazosin), 8 weeks for finasteride, 5 months for dutasteride)
- Diagnosis of Hidradenitis suppurativa
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia
The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
Read the detailed description
The Vivifi Device and procedure will be an alternative treatment for symptomatic BPH. Where other currently available treatments are generally either procedures that destroy and/or remove prostatic tissue or that involve a minimally-invasive surgical therapy, the Vivifi device is a less invasive percutaneous approach that does not require urethral entry, tissue removal, or implants. By addressing a contributing root cause of prostatic growth through a minimally invasive percutaneous approach, unwanted enlargement of the prostate may be halted or reversed, without damage to the prostatic tissue or urethra.These initial clinical studies will test the safety and feasibility of this approach.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Minimally invasive percutaneous ablation
- Keywords
- 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.
Minimally invasive percutaneous ablationDevice
Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive percutaneous ablation | Experimental | Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach Receives: Device: Minimally invasive percutaneous ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Number of participants experiencing device or procedure related adverse events assessed by severity and causality.
Measured: 24 month follow-up
Mean change from baseline International Prostate Symptom Score (IPSS) at 24 months
The IPSS is a validated 7-item questionnaire scored 0-25: higher scores indicate worse urinary symptoms. Mean change from baseline will be reported.
Measured: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Secondary outcomes (4)
Mean change from baseline in ejaculatory function assessed by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
The Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) is a validated, 4 item, patient-reported outcome instrument that assesses ejaculatory function and bother in men, evaluating domains of ejaculation force, volume, frequency, and satisfaction. A higher score on the first 3 domains indicates better ejaculatory function and the final domain indicates higher quality of life.
Measured: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in prostate volume (cc) measured by MRI
Mean change from baseline in prostate volume (cubic centimeters) as measured by magnetic resonance imaging (MRI) at specified follow-up time points. A reduction in prostate volume is desirable.
Measured: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in peak urinary flow rate (Qmax, mL/s) measured by uroflow
Mean change from baseline in peak urinary flow rate (Qmax, milliliters per second) as measured by uroflowmetry at specified follow-up time points.
Measured: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in post-void residual volume (PVR, mL) measured by ultrasound or bladder scan
Mean change from baseline in post-void residual urine volume (PVR, milliliters) as measured by ultrasound or bladder scan at specified follow-up time points.
Measured: Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionDec 2028 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivifi Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RQM Plus
- Responsible party
- Sponsor
- Investigators
- Daniel Root, MD, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745621
- Sponsor's protocol ID
- CIP-US-001
- Acronym
- BPH
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 4 Aug 2026
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT07745621
- Acronym / sponsor ID
- BPH / CIP-US-001
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- BPH
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Vivifi MedicalIndustry (pharma, biotech, devices)
- Collaborators
- RQM Plus
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 4 Aug 2026 (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 study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
Detailed description
The Vivifi Device and procedure will be an alternative treatment for symptomatic BPH. Where other currently available treatments are generally either procedures that destroy and/or remove prostatic tissue or that involve a minimally-invasive surgical therapy, the Vivifi device is a less invasive percutaneous approach that does not require urethral entry, tissue removal, or implants. By addressing a contributing root cause of prostatic growth through a minimally invasive percutaneous approach, unwanted enlargement of the prostate may be halted or reversed, without damage to the prostatic tissue or urethra.These initial clinical studies will test the safety and feasibility of this approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive percutaneous ablation | Experimental | Device: Minimally invasive percutaneous ablationPercutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male 45-80 years of age
- Diagnosed with Benign prostatic hyperplasia (BPH)
- Prostate volume: ≥ 40 ≤ 100 cc measured by MRI
- Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL)
- Assessment of future paternity plans
Key exclusion criteria (14 listed)
- Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.
- Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable
- Intravesical prostatic protrusion (IPP) > 10 mm
- Post-void residual volume (PVR) > 200ml
- IPSS QoL score ≤ 3
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 |
|---|---|---|
| Minimally invasive percutaneous ablationPercutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach | Device | Minimally invasive percutaneous ablation |
Primary outcome
Primary Safety Endpoint
Time frame: 24 month follow-up
Number of participants experiencing device or procedure related adverse events assessed by severity and causality.
Mean change from baseline International Prostate Symptom Score (IPSS) at 24 months
Time frame: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
The IPSS is a validated 7-item questionnaire scored 0-25: higher scores indicate worse urinary symptoms. Mean change from baseline will be reported.
4 secondary outcomes
Mean change from baseline in ejaculatory function assessed by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)
Time frame: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in prostate volume (cc) measured by MRI
Time frame: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in peak urinary flow rate (Qmax, mL/s) measured by uroflow
Time frame: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Mean change from baseline in post-void residual volume (PVR, mL) measured by ultrasound or bladder scan
Time frame: Baseline, 1 month, 3 months, 6 months, 18 months, 24 months 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 4 Aug 2026.
- 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.
Daniel Root, MD study chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimally invasive percutaneous ablation in people with Benign Prostatic Hyperplasia, run by Vivifi Medical at 1 site in Panama.
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 7 inclusion and 14 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: opening soon, as of the sponsor's last update on 4 Aug 2026. 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 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?
Contact Daniel Root, MD (503-757-5281, dan@vivifimedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 24 month follow-up). The study lists 2 primary outcomes in all. 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 4 Aug 2026.