Actively Recruiting
Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
Led by Vivifi Medical · Updated on 2025-04-11
20
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
Sponsors
V
Vivifi Medical
Lead Sponsor
R
RQM+
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Vivifi's Treatment, BPH Treatment Via Vasculature Anastomosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male 40-75 years of age
- Diagnosed with benign prostatic hyperplasia (BPH)
- Prostate volume between 30 and 120 cc measured by transrectal ultrasound
- Signed the study informed consent form
- Lower urinary tract symptoms with International Prostate Symptoms Score (IPSS) greater than 12
- Presence of clinical varicocele, preferably grade II or III (Dubin & Amelar)
You will not qualify if you...
- Prior surgeries or impairment related to spermatic vein or pampiniform plexus, or vasectomy
- Previous invasive prostate interventions like TURP, laser, ablation, or prostate artery embolization
- Prostate with large intravesical median lobe
- Sub-clinical varicocele
- Post-void residual volume greater than 110 ml
- IPSS greater than 24
- History of chronic prostatitis
- History of urinary retention with catheterization in the past 30 days
- Major neurological conditions such as Alzheimer's, Parkinson's, multiple sclerosis, ALS, or spinal cord injury
- Unable to undergo general anesthesia
- Use of blood thinners or coagulation issues like TTP
- Prior pelvic floor surgery or conditions such as inguinal hernia or mesh
- History of genitourinary cancer not considered cured (no evidence of cancer within 5 years)
- Inability to provide informed consent or comply with follow-up
- Currently participating in other investigational studies without sponsor approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital Paitilla
Panama City, Provincia de Panamá, Panama
Actively Recruiting
Research Team
Y
Yunlong Zhang, Master of Science
CONTACT
T
Tushar Sharma, CEO of Vivifi (Study sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here