The ProVerum First in Man PROVE Study

A clinical evaluation to assess the safety and performance of the ProVeeTM Urethral Expander System, designed to alleviate the symptoms of Benign Prostatic Hyperplasia (BPH).

Study Overview

• Status: Completed
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: The ProVee Urethral Expander System

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia
      • The Royal Melbourne Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males ≥ 50 years of age
• Moderate-to-severe symptomatic BPH
• IPSS of > 15
• Peak urinary flow rate (Qmax) of <12 mL/s
• Prostate volume of ≥ 30 and ≤80 cc
• Prostatic urethral lengths ≥ 4cm

Exclusion Criteria:

• A prostatic urethral length of less than 4cm
• A prostatic volume <30cc or >80cc
• An obstructing intravesical prostatic median lobe
• Urinary incontinence due to an incompetent external sphincter
• Urethral pathologies that may prevent insertion of delivery system
• A current symptomatic urinary tract infection
• Current significant visible haematuria
• Patients with known allergy to nickel or titanium
• History of significant medical co-morbidity or prior surgery that may confound the results of the Study
• Another medical condition that would pose an unacceptable patient risk
• Known or suspected urological condition that may affected voiding function
• Neurogenic bladder and/or sphincter abnormalities
• Patients with cognitive disabilities unable to understand and give informed consent to the research study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms	Device: The ProVee Urethral Expander System; The ProVee Urethral Expander System is supplied as a single use, sterile device and consists of a nitinol expander implant and custom implant delivery system. The delivery system is designed to allow the implant to be deployed under direct vision.; Other Names: The ProVee Expander

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deployment of the Implant	Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment endoscopy	Immediately after the implant deployment procedure
Expansion of the Implant	Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment CT	Within 24 hours of the implant deployment procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period		Immediately after the implant deployment procedure, within 24 hours
Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years		2 years
Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms	Change in symptom score using the Improvement in International Prostate Symptom Score and Quality of Life score instrument within the 2 year follow up period	2 years
Preliminary assessment of the effectiveness of the procedure in improving urinary flow	Change in Qmax measurement within the 2 year follow up period	2 years

Collaborators and Investigators

• Sponsor: ProVerum Medical

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): November 27, 2023

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CIP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No