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Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis

NCT06424912 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-11

No results posted yet for this study

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.

Conditions

  • Benign Prostatic Hyperplasia
  • Varicocele Grade II
  • Varicocele 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.

Sponsors & Collaborators

  • RQM+

    collaborator INDUSTRY

  • Vivifi Medical

    lead INDUSTRY

Principal Investigators

  • Nathan Starke, MD · Vivifi Medical (Chief Medical Officer)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2026-04-30
Completion
2026-06-30

Countries

  • Panama

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06424912 on ClinicalTrials.gov