ProVIDE II Bridging Study

NCT06236802 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CIP 003
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 8

Brief 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.

Conditions

BPH With Symptomatic Lower Urinary Tract Symptoms

Keywords

BPH / LUTS

Outcome Measures

Primary Outcomes (3)

• Serious Adverse Events

  Rate of device or procedure related serious adverse events through 3-months.

  (time frame: procedure to 3 months)

• Need for urinary catheterization

  The rate of extended post-operative urinary catheterization (\> 7 days from treatment) for inability to void among patients treated with the ProVee System for BPH.

  (time frame: >7 days post procedure to 3-months)

• Technical Success

  The percentage of subjects where the expander is deployed in the location intended by the user. This endpoint will be met if the Observed Technical Success is \>95%.

  Procedure

Study Arms (1)

ProVee treatment

EXPERIMENTAL

ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.

Device: ProVee device

Interventions

ProVee device DEVICE

ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.

Also known as: ProVee Expander, ProVee

ProVee treatment

Eligibility Criteria

• Age: 45 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Void volume \<125 ml; Qmax \> 12 ml/s; PVR \> 250 ml
• 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''
• High bladder neck, with the absence of lateral lobe encroachment indicating a high likelihood of primary bladder neck obstruction
• 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
• Acute urinary retention
• Known immunosuppression
• History of or suspected prostate or bladder cancer
• 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).
• Recent urinary tract stones OR widespread calcifications on the prostatic urethral wall, within 3 months of index procedure
• A history of prostatitis within the last two years
• Active or history of epididymitis within the past 3 months
• Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes
• History of urinary retention within 12 months of baseline assessment
• Requiring self-catheterization to void
• An active urinary tract infection (UTI) at time of index procedure

Sponsors & Collaborators

• ProVerum Medical: lead

Study Sites (8)

Florida Urology Partners, LLP

Tampa, Florida, 33606, United States

Location

Avant Concierge Urology

Winter Garden, Florida, 34787, United States

Location

Comprehensive Urologic Care

Lake Barrington, Illinois, 60010, United States

Location

Sheldon Freeman MD LTD

Las Vegas, Nevada, 89144, United States

Location

Midtown Urology Assoc. PA

Austin, Texas, 78705, United States

Location

Urology Austin

Austin, Texas, 78745, United States

Location

Houston Methodist Research Institute

Houston, Texas, 770030, United States

Location

St James Hospital

Dublin, Ireland

Location

Related Links

• ProVerum Website

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

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: January 24, 2024
• First Posted: February 1, 2024
• Study Start: March 6, 2024
• Primary Completion: September 6, 2024
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7); IE (1)