Benign Prostatic HyperplasiaNCT03972371
The ProVerum First in Man PROVE Study
A study testing The ProVee Urethral Expander System in people with Benign Prostatic Hyperplasia, run by ProVerum Medical at 1 site in Australia.
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). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- The ProVee Urethral Expander System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 13 May 2019to 27 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- The ProVee Urethral Expander System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ProVee Urethral Expander SystemDevice
Also called The ProVee Expander
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms Receives: Device: The ProVee Urethral Expander System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately after the implant deployment procedure
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
Measured: Within 24 hours of the implant deployment procedure
Secondary outcomes (4)
Rate of complications e.g. difficulty with urination, related to the implant use peri-procedurally and in the immediate follow up period
Measured: Immediately after the implant deployment procedure, within 24 hours
Rate of complications e.g. pain, difficulty with urination, related to the implant throughout the follow-up period of 2 years
Measured: 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
Measured: 2 years
Preliminary assessment of the effectiveness of the procedure in improving urinary flow
Change in Qmax measurement within the 2 year follow up period
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start13 May 2019
- Primary completion1 Dec 2021
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non-randomised, single centre, safety and feasibility study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProVerum Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972371
- Sponsor's protocol ID
- CIP-001
- Status last verified
- Nov 2023
- First submitted
- 17 May 2019
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ProVerum First in Man PROVE Study
- ClinicalTrials.gov ID
- NCT03972371
- Acronym / sponsor ID
- CIP-001
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ProVerum MedicalIndustry (pharma, biotech, devices)
- Study start
- 13 May 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non-randomised, single centre, safety and feasibility study
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: The ProVee Urethral Expander SystemThe ProVee Urethral Expander is implanted into the prostatic urethra to treat BPH symptoms |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The ProVee Urethral Expander SystemAlso: The ProVee ExpanderThe 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. | Device | Treatment Group |
Primary outcome
Deployment of the Implant
Time frame: Immediately after the implant deployment procedure
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
Time frame: Within 24 hours of the implant deployment procedure
Successful deployment of the implant from the delivery system in the target location within the prostatic urethra, as assessed with post deployment CT
4 secondary outcomes
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
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
Preliminary assessment of the effectiveness of the procedure in alleviating LUTS voiding symptoms
Time frame: 2 years
Preliminary assessment of the effectiveness of the procedure in improving urinary flow
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The ProVee Urethral Expander System in people with Benign Prostatic Hyperplasia, run by ProVerum Medical at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deployment of the Implant (time frame: Immediately after the implant deployment procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.