Could a tiny scrotal procedure ease prostate troubles without surgery?
NCT ID NCT07745621
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial tests a new device called Vivifi that aims to reduce symptoms of an enlarged prostate (BPH) by gently altering the blood supply to the prostate through a small scrotal procedure. The study involves 20 men aged 45–80 with moderate-to-severe urinary symptoms. Researchers will check how safe the procedure is and whether it improves urinary flow and symptoms over time, while also monitoring effects on ejaculatory function.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vivifi device – a minimally invasive percutaneous ablation device that modifies the prostate's blood supply via a scrotal approach
- What this could lead to
- If successful, this could offer a new, less invasive treatment option for men with enlarged prostate, potentially preserving sexual function while relieving urinary symptoms.
- What could go wrong
- This is a very early, small study (20 men) focused on safety and feasibility, so results may not hold up in larger trials. Risks include procedure-related side effects and the possibility that symptom relief is modest or temporary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 80 years
- Sex
-
Male participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Benign prostatic hyperplasia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Hospital Paitilla
Panama City, Provincia de Panamá, Panama
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- One surgery or two? trial tests prostate removal during bladder stone operation
- Laser prostate surgery that spares ejaculation put to a Five-Year test
- Virtual basket laser mode put to the test for faster prostate surgery
- Steam therapy vs. surgery: can a less invasive fix help men with blocked urine flow?
- Listening to patients: a new way to guide prostate treatment?
- A surgical twist that could save ejaculation during prostate surgery