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NCT Number: NCT07745621

Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia

The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Paitilla

Panama City, Provincia de Panamá, Panama

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Minimally invasive percutaneous ablation

Device

Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: 24 month follow-up

    Number of participants experiencing device or procedure related adverse events assessed by severity and causality.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. Procedure Duration

    Time frame: Day of procedure

    Time of procedure in minutes

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Root, MD

CONTACT

[email protected]

503-757-5281

Susan Brief, MS

CONTACT

[email protected]

612-309-1320

Sponsors and collaborators

Lead sponsor

Vivifi Medical

Industry

Collaborators

  • RQM Plus

Registry information

Official study title

Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia

Acronym: BPH

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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