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โ† Trials
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Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis

RecruitingNAAges 40 Years - 75 YearsMaleVivifi Medical
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male 40-75 years of age 2. Diagnosed with Benign prostatic hyperplasia (BPH) 3. Prostate volume: โ‰ฅ 30 โ‰ค 120 cc measured by transrectal ultrasound 4. Signed the study informed consent form (ICF) 5. Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12 6. Presence of clinical varicocele (preferably grade II or III - Dubin \& Amelar. Exclusion Criteria: 1. Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy 2. Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.) 3. Prostate with large intravesical median lobe 4. Patients with sub-clinical varicocele 5. Post-void residual volume (PVR) \> 110ml 6. IPSS (International Prostate Symptoms Score) \>24 7. Patients with clinical history of chronic prostatitis. 8. Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days). 9. Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury 10. Patients that can not be under general anesthesia 11. Patients on blood thinners, or with coagulation related issues, TTP 12. Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc 13. 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. 14. Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements 15. Subject currently participating in other investigational studies unless approved by the Sponsor in writing
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What it tests

  • Vivifi's Surgical Procedure
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Where

1 site
Hospital Paitilla
Panama City, Panama
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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