Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis

Recruiting now · Not applicable

Conditions studied: Benign Prostatic Hyperplasia, Varicocele Grade II, Varicocele Grade III

In brief

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. The scientific rationale for conducting this study is to assess the safety and feasibility of the Vivifi's Treatment (a surgical procedure) as a therapeutic intervention for patients with BPH.

Key facts

Study ID

NCT06424912

Run by

Vivifi Medical

People needed

20

Starts

2024-11-13

Expected to finish

2026-06-30

Last updated by the study team

2025-04-11

Who can join

Age: 40 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify 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
• Presence of clinical varicocele (preferably grade II or III - Dubin \& Amelar.

You may not qualify 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
• 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

Where it is running

• Hospital Paitilla — Panama City, Provincia de Panamá, Panama (enrolling)

Full record on ClinicalTrials.gov

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