RecruitingNot ApplicableNCT06424912

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

Sponsor

Vivifi Medical

Enrollment

20 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

Benign Prostatic Hyperplasia Varicocele Grade II Varicocele Grade III

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.

Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 75 Years

Inclusion Criteria6

Male 40-75 years of age
Diagnosed with Benign prostatic hyperplasia (BPH)
Prostate volume: ≥ 30 ≤ 120 cc measured by transrectal ultrasound
Signed the study informed consent form (ICF)
Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12
Presence of clinical varicocele (preferably grade II or III - Dubin \& Amelar.

Exclusion Criteria15

Patients with prior history of spermatic vein or pampiniform plexus related surgeries or impairment, or vasectomy
Previous invasive prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.)
Prostate with large intravesical median lobe
Patients with sub-clinical varicocele
Post-void residual volume (PVR) \> 110ml
IPSS (International Prostate Symptoms Score) \>24
Patients with clinical history of chronic prostatitis.
Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days).
Major neurological conditions such as Alzheimer's, Parkinson, Multiple sclerosis, ALS, spinal cord injury
Patients that can not be under general anesthesia
Patients on blood thinners, or with coagulation related issues, TTP
Prior pelvic floor surgery or condition such as inguinal hernia, mesh, etc
History of cancer in genitourinary system, which is not considered being cured. A potential participant is considered cured if there has been no evidence of cancer within five years of the study.
Inability to provide legally effective Informed Consent Form (ICF) and/or comply with all of the required follow-up requirements
Subject currently participating in other investigational studies unless approved by the Sponsor in writing

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Interventions

PROCEDUREVivifi'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.