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New treatment option for Benign Prostatic Hyperplasia
Official title Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
ClinicalTrials.gov ID: NCT06424912
What this study is testing
- What it's testing
- The study objective is to evaluate the safety and feasibility of the Vivifi's Treatment. The Vivifi's Treatment presents an innovative approach for addressing benign prostatic hyperplasia (BPH) as well as clinical/subclinical varicoceles in men.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75, men only
You may be able to join if
- Male 40-75 years of age
- Diagnosed with Benign prostatic hyperplasia (BPH)
- Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound
- Signed the study informed consent form (ICF)
- Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
You likely can't join if
- Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy
- Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)
- Prostate with large intravesical median lobe
- Patients with sub-clinical varicocele
- Post-void residual volume (PVR) \> 110ml
- IPSS (International Prostate Symptoms Score) \>24
See the full eligibility criteria
- Male 40-75 years of age
- Diagnosed with Benign prostatic hyperplasia (BPH)
- Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound
- Signed the study informed consent form (ICF)
- Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
- Presence of clinical varicocele (preferably grade II or III - Dubin \& Amelar.
- Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy
- Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)
- Prostate with large intravesical median lobe
- Patients with sub-clinical varicocele
- Post-void residual volume (PVR) \> 110ml
- IPSS (International Prostate Symptoms Score) \>24
- Patients with clinical history of chronic prostatitis.
- Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days).
- Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
- Patients that can not be under general anesthesia
- Patients on blood thinners, or with coagulation related issues, TTP
- Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc
- History of cancer in genitourinary system, which is not considered being cured. A potential participant is considered cured if there has been no evidence of cancer within five years of the study.
- Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements
- Subject currently participating in other investigational studies unless approved by the Sponsor in writing
The study team makes the final eligibility decision.
Where it's taking place
- Panama City, Provincia de Panamá, Panama
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Panama City, Provincia de Panamá, Panama. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.