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Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
Sponsor: Vivifi Medical
Summary
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.
Official title: Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein
Key Details
Gender
MALE
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-11-13
Completion Date
2026-06-30
Last Updated
2025-04-11
Healthy Volunteers
No
Interventions
Vivifi's Surgical Procedure
Subjects undergo Vivifi's surgical procedure for treatment of BPH. The study procedure will be performed in the operating room, under general anesthesia. Subject will undergo a bilateral anastomosis of the internal spermatic vein to the inferior epigastric vein and ligation of the deferential vein via bilateral inguinal/subinguinal incision. The investigators can use of a coupler with appropriate ring size (to be measured intra-operatively based on vessel size) to perform the vascular anastomosis and standard sutures for ligation. The coupler is an FDA approved commercial device. Alternatively, the anastomosis can also be performed using sutures. Incision closure will proceed per institution standard of care.
Locations (1)
Hospital Paitilla
Panama City, Provincia de Panamá, Panama