Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Minimally invasive percutaneous ablation.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: 45 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Panama
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia
Overview
The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
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.
Interventions
- 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 outcome measures
- Primary Safety Endpoint [Time frame: 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.]
Secondary outcome measures (4)
- 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.]
- 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 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 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Panama · 1 center
- Hospital Paitilla — Panama City
Identifiers
NCT: NCT07745621 · CIP-US-001