Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-75
SponsorVivifi Medical
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Vivifi's Surgical Procedure
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Vivifi Medical
Lead sponsor
RQM+
Collaborator
Source ClinicalTrials.gov