BPH With Symptomatic Lower Urinary Tract SymptomsNCT07680543
ProVIDE Studies Post Exit Analysis
An observational study of BPH With Symptomatic Lower Urinary Tract Symptoms, run by ProVerum Medical.
Trial summary
A study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- BPH With Symptomatic Lower Urinary Tract Symptoms
- What is being tested?
- ProVee Urethral Expander System
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 31 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: All US based subjects who exited from the ProVIDE or ProVIDE II studies.
Who may be able to join
- 1. US based subjects previously enrolled in the ProVIDE Study or the ProVIDE II Bridging Study who had a ProVee device removed.
- 2. Subjects who withdrew consent or were withdrawn by site Study PI.
- 3. Subjects consented to make data available.
Who cannot join
- 1. Incomplete records available.
- 2. Subjects who exited the studies due to restarting BPH medication while they were enrolled.
- 3. Subjects who did not receive a ProVee in the ProVIDE Study or the ProVIDE II Bridging Study.
- 4. Subjects who exited the studies due to prostate cancer.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
A study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.
Read the detailed description
An analysis of US based subjects who exited from the ProVIDE or ProVIDE II studies.
- Being tested
- ProVee Urethral Expander System
- Keywords
- BPH / LUTS
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProVee Urethral Expander SystemDevice
Also called ProVee Expander, ProVee
ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
| Study group | Role | What they receive |
|---|---|---|
| Observational Group | US based subjects who exited from the ProVIDE or ProVIDE II studies. Receives: Device: ProVee Urethral Expander System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start30 Sep 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH With Symptomatic Lower Urinary Tract SymptomsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ProVerum Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680543
- Sponsor's protocol ID
- CIP-004
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProVIDE Studies Post Exit Analysis
- ClinicalTrials.gov ID
- NCT07680543
- Acronym / sponsor ID
- CIP-004
- Keywords
- BPH / LUTS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- ProVerum MedicalIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 2 Jul 2026 (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 study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.
Detailed description
An analysis of US based subjects who exited from the ProVIDE or ProVIDE II studies.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational Group | – | Device: ProVee Urethral Expander SystemUS based subjects who exited from the ProVIDE or ProVIDE II studies. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All US based subjects who exited from the ProVIDE or ProVIDE II studies.
Key inclusion criteria (3 listed)
- 1. US based subjects previously enrolled in the ProVIDE Study or the ProVIDE II Bridging Study who had a ProVee device removed.
- 2. Subjects who withdrew consent or were withdrawn by site Study PI.
- 3. Subjects consented to make data available.
Key exclusion criteria (4 listed)
- 1. Incomplete records available.
- 2. Subjects who exited the studies due to restarting BPH medication while they were enrolled.
- 3. Subjects who did not receive a ProVee in the ProVIDE Study or the ProVIDE II Bridging Study.
- 4. Subjects who exited the studies due to prostate cancer.
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 |
|---|---|---|
| ProVee Urethral Expander SystemAlso: ProVee Expander, ProVeeProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH. | Device | Observational Group |
Primary outcome
Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- ProVerum WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of BPH With Symptomatic Lower Urinary Tract Symptoms, run by ProVerum Medical.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane Gargus (1-720-472-1504, diane@proverummedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy. (time frame: Up to 36 months). 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 3 Sep 2026.