An interventional study of Minimally invasive percutaneous ablation in Benign Prostatic Hyperplasia, sponsored by Vivifi Medical. Not yet recruiting at 1 site in Panama. Open to male participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Vivifi Medical · Not applicable, Interventional, and Treatment
The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 20 is below the median of 92 across 626 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Vivifi Medical is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Primary Safety Endpoint
Number of participants experiencing device or procedure related adverse events assessed by severity and causality.
Time frame: 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.
Time frame: From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
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.
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
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.
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
Mean change from baseline in peak urinary flow rate (Qmax, milliliters per second) as measured by uroflowmetry at specified follow-up time points.
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
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.
Time frame: Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.
Procedure Duration
Time of procedure in minutes
Time frame: Day of procedure
Change from baseline in serum PSA (ng/dl) and testosterone (ng/dl)
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.
Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 24 months
Cystoscopic assessment of urethral and bladder integrity
Cystoscopic evaluation of urethral and bladder mucosal integrity at specified follow-up time points to assess for procedure-related anatomical changes or adverse findings.
Time frame: From baseline, 1 month, 3 months, 6 months, 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.
Of 51 industry-sponsored interventional studies with no phase under Prostatic Hyperplasia, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 50. This study's planned 5 months is below that.
Counting every sponsor, half of 203 studies reached it within 26 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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