Not Yet RecruitingNot Applicable

Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia

Panama20 participantsStarted 2026-09

Plain-language summary

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

Who can participate

Age range

45 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Primary Safety Endpoint

Timeframe: 24 month follow-up

Mean change from baseline International Prostate Symptom Score (IPSS) at 24 months

Timeframe: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

Trial details

NCT IDNCT07745621

SponsorVivifi Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Daniel Root, MD

503-757-5281 dan@vivifimedical.com

View on ClinicalTrials.gov More Benign Prostatic Hyperplasia trials