The ProVerum First in Man PROVE Study

ProVerum Medical

Status

Completed

Conditions

Benign Prostatic Hyperplasia

Treatments

Device: The ProVee Urethral Expander System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03972371

CIP-001

Details and patient eligibility

About

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).

Enrollment

10 patients

Sex

Male

Ages

50+ years old

Volunteers

No 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