Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia (BPH)

July 29, 2026 updated by: Vivifi Medical

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Panama
    • Provincia de Panamá
      • Panama City, Provincia de Panamá, Panama
        • Hospital Paitilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male 45-80 years of age
  2. Diagnosed with Benign prostatic hyperplasia (BPH)
  3. Prostate volume: ≥ 40 ≤ 100 cc measured by MRI
  4. Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL)
  5. Assessment of future paternity plans
  6. Signed the study informed consent
  7. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12

Exclusion Criteria:

  1. Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.
  2. Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable
  3. Intravesical prostatic protrusion (IPP) > 10 mm
  4. Post-void residual volume (PVR) > 200ml
  5. IPSS QoL score ≤ 3
  6. Prostate cancer diagnosis, suspicious DRE, or PSA > 10ng/mL
  7. Patients with clinical history of chronic prostatitis.
  8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures.
  9. Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury
  10. Patients who are unable to undergo the required anesthesia for the procedure
  11. Patients on testosterone replacement therapy
  12. Patients unable to hold blood thinners, or with coagulation related issues
  13. 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)
  14. Diagnosis of Hidradenitis suppurativa

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Minimally invasive percutaneous ablation
Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach
Device: Minimally invasive percutaneous ablation
Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: 24 month follow-up
Number of participants experiencing device or procedure related adverse events assessed by severity and causality.
24 month follow-up
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.
From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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 prostate volume (cubic centimeters) as measured by magnetic resonance imaging (MRI) at specified follow-up time points. A reduction in prostate volume is desirable.
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 peak urinary flow rate (Qmax, milliliters per second) as measured by uroflowmetry at specified follow-up time points.
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.
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.
Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Procedure Duration
Time Frame: Day of procedure
Time of procedure in minutes
Day of procedure
Change from baseline in serum PSA (ng/dl) and testosterone (ng/dl)
Time Frame: Baseline, 1 month, 3 months, 6 months, 12 months, 24 months
Mean change from baseline in serum prostate-specific antigen (PSA, nanograms per milliliter) and total testosterone (nanograms per deciliter) as measured by standard laboratory assay at specified follow-up time points.
Baseline, 1 month, 3 months, 6 months, 12 months, 24 months
Cystoscopic assessment of urethral and bladder integrity
Time Frame: From baseline, 1 month, 3 months, 6 months, 12 months
Cystoscopic evaluation of urethral and bladder mucosal integrity at specified follow-up time points to assess for procedure-related anatomical changes or adverse findings.
From baseline, 1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vivifi Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RQM Plus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Daniel Root, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CIP-US-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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