20
Participants
Start Date
November 13, 2024
Primary Completion Date
April 30, 2026
Study Completion Date
June 30, 2026
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."
RECRUITING
Hospital Paitilla, Panama City
Collaborators (1)
RQM+
INDUSTRY
Vivifi Medical
INDUSTRY