Post-Exit Look at Reinterventions After ProVee Device Removal
Official title: ProVIDE Studies Post Exit Analysis
Run by ProVerum Medical · NCT07680543 · Data updated 2026-11-12
This study tests whether patients who left the ProVIDE studies and had a ProVee urethral expander removed go on to need secondary procedures for their LUTS.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 45 Years and up |
| Sex | Men only |
| Enrollment | 25 (estimated) |
| Sponsor | ProVerum Medical Industry-sponsored |
| Locations | 1 site (Lake Barrington, Illinois) |
| Status | Recruiting |
| Started | September 30, 2026 |
| Main results expected | July 31, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07680543 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
US-based individuals who were enrolled in ProVIDE or ProVIDE II, had a ProVee removed, and consented to data use.
✕Probably not a fit
Patients who did not receive a ProVee device, those with incomplete records, or those who restarted BPH medications while in the study are unlikely to gain information from this analysis.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational analysis collects data from US participants who exited the ProVIDE or ProVIDE II studies after ProVee device removal. It focuses on the incidence of secondary LUTS-related interventions following exit. The study uses existing records to describe post-exit outcomes and is limited to those who consented to data use and meet inclusion criteria. Subjects who restarted BPH medications, lacked complete records, or did not receive a ProVee device are excluded. Lead sponsor is ProVerum Medical with site participation at Comprehensive Urologic Care in Illinois.
Why it matters
Potential benefit: If successful, the study could clarify post-exit treatment pathways and help guide expectations for patients considering or leaving ProVee-related care.
How similar studies have gone: Previous investigations in device-related reinterventions have shown variable rates; this analysis adds post-exit data for a specific urethral expander program.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where it's running
-
Comprehensive Urologic Care
Lake Barrington, Illinois, United States Recruiting
Study contacts
- Study coordinator: Diane Gargus
- Email: diane@proverummedical.com
- Phone: 1-720-472-1504
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.