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The ProVerum First in Man PROVE Study

Primary Purpose

Benign Prostatic Hyperplasia

Status

Active

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

The ProVee Urethral Expander System

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

The Royal Melbourne Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

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

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

Change in Qmax measurement within the 2 year follow up period

Full Information

NCT ID

NCT03972371

First Posted

May 17, 2019

Last Updated

March 27, 2023

Sponsor

ProVerum Medical

1. Study Identification

Unique Protocol Identification Number

NCT03972371

Brief Title

The ProVerum First in Man PROVE Study

Official Title

The ProVerum First in Man PROVE Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 13, 2019 (Actual)

Primary Completion Date

December 1, 2021 (Actual)

Study Completion Date

October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ProVerum Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Prospective, non-randomised, single centre, safety and feasibility study

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

The ProVee Urethral Expander System

Other Intervention Name(s)

The ProVee Expander

Intervention Description

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.

Primary Outcome Measure Information:

Title

Deployment of the Implant

Description

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

Time Frame

Immediately after the implant deployment procedure

Title

Expansion of the Implant

Description

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

Time Frame

Within 24 hours of the implant deployment procedure

Secondary Outcome Measure Information:

Title

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

Title

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

Title

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

Description

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

Time Frame

2 years

Title

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

Description

Change in Qmax measurement within the 2 year follow up period

Time Frame

2 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

The Royal Melbourne Hospital

City

Melbourne

State/Province

Victoria

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

The ProVerum First in Man PROVE Study

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