The ProVerum First in Man PROVE Study

Benign Prostatic Hyperplasia Clinical Trial

Official title:

The ProVerum First in Man PROVE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03972371
• Other study ID #: CIP-001
• Status: Completed
• Phase: N/A
• Start date: May 13, 2019
• Est. completion date: November 27, 2023

Study information

• Verified date: November 2023
• Source: ProVerum Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 27, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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.

Locations

Country	Name	City	State
Australia	The Royal Melbourne Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
ProVerum Medical

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years		2 years
Secondary	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
Secondary	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