Vivifi Device Safety Evaluation for the Treatment of Benign Prostatic Hyperplasia

NCT07745621 | Not Yet Recruiting

• 1 other identifier: CIP-US-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

BPH

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

  Number of participants experiencing device or procedure related adverse events assessed by severity and causality.

  24 month follow-up

• Mean change from baseline International Prostate Symptom Score (IPSS) at 24 months

  The IPSS is a validated 7-item questionnaire scored 0-25: higher scores indicate worse urinary symptoms. Mean change from baseline will be reported.

  From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

Secondary Outcomes (4)

• Mean change from baseline in ejaculatory function assessed by Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD)

  From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

• Mean change from baseline in prostate volume (cc) measured by MRI

  From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

• Mean change from baseline in peak urinary flow rate (Qmax, mL/s) measured by uroflow

  From baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

• Mean change from baseline in post-void residual volume (PVR, mL) measured by ultrasound or bladder scan

  Baseline, 1 month, 3 months, 6 months, 18 months, 24 months post-procedure.

Other Outcomes (3)

• Procedure Duration

  Day of procedure

• Change from baseline in serum PSA (ng/dl) and testosterone (ng/dl)

  Baseline, 1 month, 3 months, 6 months, 12 months, 24 months

• Cystoscopic assessment of urethral and bladder integrity

  From baseline, 1 month, 3 months, 6 months, 12 months

Study Arms (1)

Minimally invasive percutaneous ablation

EXPERIMENTAL

Percutaneous ablation will be used to modify the vascular supply to the prostate via a minimally invasive scrotal approach

Device: Minimally invasive percutaneous ablation

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

Minimally invasive percutaneous ablation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Gender Eligibility Details: cisgender men; males
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vivifi Medical: lead
• RQM Plus: collaborator

Study Sites (1)

Hospital Paitilla

Panama City, Provincia de Panamá, Panama

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Daniel Root, MD

  STUDY CHAIR

Central Study Contacts

Daniel Root, MD

CONTACT

503-757-5281; dan@vivifimedical.com

Susan Brief, MS

CONTACT

612-309-1320; sue.brief@clinical-research-pro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)