Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia

Sponsor
Vivifi Medical
Study ID
NCT07745621
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
MALE
Age
45 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Minimally invasive percutaneous ablation — DEVICE
    Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach

Study Details

The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).

Key Dates

First listed
Aug 4, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Feb 28, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Minimally invasive percutaneous ablation
    Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: 24 month follow-up ]

Central Contacts

Related Studies