NCT06424912

Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis

Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis of the Internal Spermatic Vein and Ligation of the Deferential Vein

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Vivifi Medical · Industry
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Current BPH treatments fall into two major categories: 1. Surgical removal/destruction of prostatic tissues: 1. Transurethral resection of the prostate (TURP) 2. Holmium laser enucleation of the prostate (HoLEP) 3. Aquablation - (Procept) 4. Prostatic artery embolization (PAE) 2. Minimally-invasive Surgical Therapies (MISTs) 1. Itind (now Olymus) 2. Urolift (now Teleflex) 3. Rezum (now Boston Scientific) 4. TUNA 5. Zenflow (in trials) 6. Butterfly Medical (in trials) 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.

Conditions

• Benign Prostatic Hyperplasia
• Varicocele Grade II
• Varicocele Grade III

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-13
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2024-05-22
• Last updated: 2025-04-11

Locations

1 site across 1 country: Panama