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
This trial does not accept healthy volunteersQualifiers
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 Subjects who withdrew consent or were withdrawn by site Study PI.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 population
All US based subjects who exited from the ProVIDE or ProVIDE II studies.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
ProVee Urethral Expander System
DeviceProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Observational Group1 intervention
Trial outcomes
Primary outcomes
1
Post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.
Time frame
Up to 36 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: