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Completed

NCT Number: NCT03972371

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).

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The ProVee Urethral Expander System

Device

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

Primary outcomes

  1. Deployment of the Implant

    Time frame: Immediately after the implant deployment procedure

    Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment endoscopy

  2. Expansion of the Implant

    Time frame: Within 24 hours of the implant deployment procedure

    Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment CT

Secondary outcomes

  1. Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period

    Time frame: Immediately after the implant deployment procedure, within 24 hours

  2. Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years

    Time frame: 2 years

  3. Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms

    Time frame: 2 years

    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

  4. Preliminary assessment of the effectiveness of the procedure in improving urinary flow

    Time frame: 2 years

    Change in Qmax measurement within the 2 year follow up period

Sponsors and collaborators

Lead sponsor

ProVerum Medical

Industry

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Jun 3, 2019
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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