Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis

NARecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 13, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

June 30, 2026

Conditions
Benign Prostatic HyperplasiaVaricocele Grade IIVaricocele Grade III
Interventions
PROCEDURE

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."

Trial Locations (1)

Unknown

RECRUITING

Hospital Paitilla, Panama City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

RQM+

INDUSTRY

lead

Vivifi Medical

INDUSTRY