Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis

Launched by VIVIFI MEDICAL · May 16, 2024

Keywords

ClinConnect Summary

The clinical trial titled "Vivifi's Treatment" is investigating a new surgical approach to treat benign prostatic hyperplasia (BPH), a condition that can cause difficulties with urination in men. This study aims to see if the Vivifi's Treatment is safe and practical for men aged 40 to 75 who have been diagnosed with BPH and experience bothersome urinary symptoms. To participate, men must have a prostate size within a certain range and have symptoms that score above a specific threshold on a standardized questionnaire.

If eligible and chosen for the trial, participants will undergo the Vivifi's Treatment and will be monitored for safety and effectiveness. This is a great opportunity for men dealing with BPH and related conditions like varicocele, which is an enlargement of veins within the scrotum. However, there are certain health conditions and previous surgeries that may prevent someone from joining the trial. Overall, the study is actively recruiting participants and aims to provide valuable insights into this innovative treatment option for BPH.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Male 40-75 years of age
• • 2. Diagnosed with Benign prostatic hyperplasia (BPH)
• • 3. Prostate volume: ≥ 30 ≤ 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