ProVIDE II Bridging Study

ProVIDE II Bridging Study for the ProVee System for BPH

NCT06236802•ProVerum Medical

Summary

The purpose of the ProVIDE II Bridging Study is to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to BPH.

Detailed Description

This is a prospective, multi-center, open-label, non-randomized bridging study to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to benign prostatic hyperplasia (BPH).

Eligibility

Age

45 - No limit years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males \> 45 years of age
•2. IPSS of ≥ 13, IPSS V/S \> 1 at baseline assessment
•3. Prostate volume of ≥ 30 cc and ≤ 80 cc
•4. Prostatic urethral L2 lengths ≥ 3.75 cm by TRUS
•5. Failed, intolerant, or subject choice to not take a medication regimen for the treatment of LUTS.

Exclusion Criteria

•1. Void volume \<125 ml; Qmax \> 12 ml/s; PVR \> 250 ml
•2. Obstructive median lobe defined by EITHER \>10mm protrusion on sagittal mid-prostate plane as measured by TRUS OR an obstructive median lobe seen on cystoscopy e.g., 'ball valve''
•3. High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction
•4. Anatomy that would prevent the apices of the ProVee from engaging with the lateral lobes e.g., high degree of bladder neck angulation such that the anterior bladder neck is not visible
•5. Acute urinary retention
•6. Known immunosuppression
•7. History of or suspected prostate or bladder cancer
•8. Baseline PSA \> 10 ng/mL or confirmed or suspected prostate cancer (Subjects with a PSA level above 2.5 ng/mL, or age specific, or local reference ranges should have prostate cancer excluded to the Investigator's satisfaction, including a SOC biopsy if indicated).
•9. Recent urinary tract stones OR widespread calcifications on the prostatic urethral wall, within 3 months of index procedure
•10. A history of prostatitis within the last two years
+34 more criteria

Locations (8)

Florida Urology Partners, LLP

Tampa, Florida, United States

Avant Concierge Urology

Winter Garden, Florida, United States

Comprehensive Urologic Care

Lake Barrington, Illinois, United States

Sheldon Freeman MD LTD

Las Vegas, Nevada, United States

Midtown Urology Assoc. PA

Austin, Texas, United States

Urology Austin

Austin, Texas, United States

Houston Methodist Research Institute

Houston, Texas, United States

St James Hospital

Dublin, Ireland

Key Dates

Start Date

March 6, 2024

Primary Completion Date

September 6, 2024

Completion Date

June 1, 2029

Last Updated

June 10, 2025

Enrollment

ACTUAL participants

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

Interventions

ProVee device

DEVICE