Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia | NCT07745621

NCT07745621

Overview

NCT ID: NCT07745621
Lead Sponsor: Vivifi MedicalINDUSTRY
Official Title: Safety and Efficacy Evaluation of the Vivifi Device for Treatment of Symptomatic Benign Prostatic Hyperplasia
Brief Summary: The study objective is to evaluate the safety and feasibility of the Vivifi device to treat symptomatic, benign prostatic hyperplasia (BPH).
Conditions: Benign Prostatic Hyperplasia
Interventions: Minimally invasive percutaneous ablation

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 4, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Feb 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Male 45-80 years of age

Diagnosed with Benign prostatic hyperplasia (BPH)

Prostate volume: ≥ 40 ≤ 100 cc measured by MRI

Qmax ≤ 10 mL/s on two measures (voided volume ≥ 125 mL)

Assessment of future paternity plans

Signed the study informed consent

Presence of Lower Urinary Tract Symptoms (LUTS) measured by International Prostate Symptoms Score (IPSS) greater than 12

Exclusion Criteria:

Patients with prior history of relevant scrotal or testicular vascular surgeries or procedures, or vasectomy.

Previous procedural prostate intervention (TURP, laser, ablation, prostate artery embolization, etc.). Prostate biopsies are acceptable

Intravesical prostatic protrusion (IPP) > 10 mm

Post-void residual volume (PVR) > 200ml

IPSS QoL score ≤ 3

Prostate cancer diagnosis, suspicious DRE, or PSA > 10ng/mL

Patients with clinical history of chronic prostatitis.

Patients with clinical history of urinary retention with previous need for catheterization (prior 30 days), or urethral strictures.

Major neurological conditions such as Alzheimer's, Parkinsons, Multiple sclerosis, ALS, spinal cord injury

Patients who are unable to undergo the required anesthesia for the procedure

Patients on testosterone replacement therapy

Patients unable to hold blood thinners, or with coagulation related issues

Patients currently taking medication for BPH (eg. Alpha-blockers or 5-ARIs) who are unwilling or unable to discontinue (washout) prior to treatment (14 days for α-blockers (tamsulosin, alfuzosin, silodosin, doxazosin, terazosin), 8 weeks for finasteride, 5 months for dutasteride)

Diagnosis of Hidradenitis suppurativa

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 20Estimated
Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking

Contacts and Locations

Central Contacts: Daniel Root, MDContact
dan@vivifimedical.com

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