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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Panama
Hospital Paitilla
RECRUITING
Panama City
Contact Information
Primary
Yunlong Zhang, Master of Science
pzhang@rqmplus.com
669-203-9308
Backup
Tushar Sharma, CEO of Vivifi (Study sponsor)
tushar@vivifimedical.com
Time Frame
Start Date: 2024-11-13
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Treatments
Experimental: Treatment Group
Subjects undergo Vivifi's surgical procedure for treatment of BPH.
Related Therapeutic Areas
Sponsors
Collaborators: RQM+
Leads: Vivifi Medical

This content was sourced from clinicaltrials.gov