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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03972371




Registration number
NCT03972371
Ethics application status
Date submitted
17/05/2019
Date registered
3/06/2019
Date last updated
28/11/2023

Titles & IDs
Public title
The ProVerum First in Man PROVE Study
Scientific title
The ProVerum First in Man PROVE Study
Secondary ID [1] 0 0
CIP-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - The ProVee Urethral Expander System

Experimental: Treatment Group - The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Deployment of the Implant
Timepoint [1] 0 0
Immediately after the implant deployment procedure
Primary outcome [2] 0 0
Expansion of the Implant
Timepoint [2] 0 0
Within 24 hours of the implant deployment procedure
Secondary outcome [1] 0 0
Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period
Timepoint [1] 0 0
Immediately after the implant deployment procedure, within 24 hours
Secondary outcome [2] 0 0
Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Preliminary assessment of the effectiveness of the procedure in improving urinary flow
Timepoint [4] 0 0
2 years

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/11/2023
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ProVerum Medical
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT03972371
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03972371