ProVIDE Studies Post Exit Analysis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age45+
SponsorProVerum Medical
About this trial
A study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.
Eligibility criteria
Qualifiers
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 Subjects who withdrew consent or were withdrawn by site Study PI.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.
Disqualifiers
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 design
Treatments tested in this trial
- ProVee Urethral Expander System
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov