Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
10 participants
INTERVENTIONAL
2019-05-13
2023-11-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
MALE
No
Sponsors
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ProVerum Medical
INDUSTRY
Responsible Party
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Locations
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The Royal Melbourne Hospital
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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CIP-001
Identifier Type: -
Identifier Source: org_study_id