The ProVerum First in Man PROVE Study

NCT03972371 | Completed DMC

• 1 other identifier: CIP-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

  2 years

• Preliminary assessment of the effectiveness of the procedure in improving urinary flow

  2 years

Study Arms (1)

Treatment Group

EXPERIMENTAL

The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms

Device: The ProVee Urethral Expander System

Interventions

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.

Also known as: The ProVee Expander

Treatment Group

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProVerum Medical: lead

Study Sites (1)

The Royal Melbourne Hospital

Melbourne, Victoria, Australia

Location

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

Model Details: Prospective, non-randomised, single centre, safety and feasibility study

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: June 3, 2019
• Study Start: May 13, 2019
• Primary Completion: December 1, 2021
• Study Completion: November 27, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)