An interventional study of Vivifi's Surgical Procedure in Benign Prostatic Hyperplasia, Varicocele Grade II and Varicocele Grade III, sponsored by Vivifi Medical. Recruiting at 1 site in Panama. Open to male participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Vivifi Medical · Not applicable, Interventional, and Treatment
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.
Current BPH treatments fall into two major categories:
Surgical removal/destruction of prostatic tissues:
Minimally-invasive Surgical Therapies (MISTs)
The solutions in the first category rely in removing or destroying prostatic tissue. Though effective at reducing urinary symptoms, this damage to the tissue can cause a number of complications. The "non-surgical" solutions fall into the second category. One of the best-studied of these, Urolift, is an implant-based therapy, using internal sutures that are deployed though the urethra that pull the prostatic tissue away from the urethra lumen, repristinating urethral patency. A significant percentage of cases show recurrence of symptoms due to the fact that the prostate continues to grow. Looking at the currently available treatment options, the longer-lasting surgical procedure (group 1). Group 1 procedures, especially TURP, remain "the gold standard" by which all other BPH treatment options are measured.
The Vivifi's Treatment aims to fill the therapeutic gap between the two-category approaches by offering patients a less invasive surgical approach that (1) fixes the root cause of the problem, guaranteeing long lasting effects and (2) does not cause any damage to the prostatic tissue and urethra, thereby preventing the side effects mentioned above. By replumbing a faulty localized vasculature, the Vivifi's technology leverage years of safety data for anastomotic coupling rings enabling it for vascular surgical approaches. These initial clinical studies will prove that this totally novel treatment approach to BPH is safe.
Exclusion Criteria:
Subjects undergo Vivifi's surgical procedure for treatment of BPH.
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.
PRIMARY SAFETY ENDPOINT
Assess the safety of the Vivifi's Treatment through the rate \& type of the procedure related complications, such as bleeding, infection or other tissue damage.
Time frame: will be assessed up to 12-month post-procedure follow-up.
PRIMARY EFFICACY ENDPOINT
Assess the changes in International Prostate Symptoms Score (IPSS) from baseline to post-procedure. The score range of the questionnaire is 0 to 35. A higher score indicates worse symptomatic.
Time frame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
SECODARY EFFICACY ENDPOINT 1
Changes in International Index of Erectile Function (IIEF) questionnaire scores. The questionnaire has 15 questions. Each question is scored from 0-5. A higher score indicates improved erectile function.
Time frame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
SECODARY EFFICACY ENDPOINT 2
Changes in size (volume) of the prostate measured by transrectal ultrasound and cystoscope in mL.
Time frame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
SECODARY EFFICACY ENDPOINT 3
Change in peak urinary flow (Qmax) in mL/sec.
Time frame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
SECODARY EFFICACY ENDPOINT 4
Change in post-void residual urine volume in mL.
Time frame: to be assessed at baseline and post-procedure 1 months, 3 months, 6 months and 12 months follow-ups.
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