Device: The ProVee Urethral Expander System for Benign Prostatic Hyperplasia
Study Summary
This trial is studying a device to treat urinary obstruction caused by an enlarged prostate.
- Benign Prostatic Hyperplasia (BPH)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 0 Secondary · Reporting Duration: Procedure - 12 months
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Device: The ProVee Urethral Expander System
1 of 2
Sham: Ureteroscope and urethral access sheath
1 of 2
Active Control
Non-Treatment Group
225 Total Participants · 2 Treatment Groups
Primary Treatment: Device: The ProVee Urethral Expander System · Has Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18+ · Male Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
Florida | 53.7% |
Nevada | 43.5% |
Texas | 0.7% |
Other | 2.0% |
How old are they?
65+ | 100.0% |
What site did they apply to?
Sheldon Freedman MD | 45.5% |
Avant Concierge Urology | 54.5% |
What portion of applicants met pre-screening criteria?
Did not meet criteria | 43.4% |
Met criteria | 56.6% |
How many prior treatments have patients received?
0 | 71.0% |
1 | 16.1% |
2 | 9.7% |
3+ | 3.2% |
Why did patients apply to this trial?
- "Hopeful for a solution"
- "I like to help science"
- "I don’t take medications"
- "natural way to get it up."
- "I want try others options"
What questions have other patients asked about this trial?
- "is it trans urethral?"
- "How quickly can we start?"
- "Is this similar to urolift?"
- "when would the trials start?"
- "How long is this study for???"
How responsive is this trial?
Typically responds via
4.1% | |
Phone Call | 95.9% |
Most responsive sites:
- Sheldon Freedman MD: < 24 hours
- Avant Concierge Urology: < 24 hours
Average response time
- < 2 Days
Frequently Asked Questions
What is the cap on enrollment for this medical experiment?
"Indeed, the information that is posted on clinicaltrials.gov indicates that this trial has resumed its recruitment process. This study was first published on June 9th 2022 and most recent updated on July 25th 2022; thus far, 225 patients have been enrolled from two medical sites." - Anonymous Online Contributor
Is enrollment still open for this research initiative?
"According to information found on clinicaltrials.gov, enrollment for this trial is ongoing and the investigation was launched on June 9th 2022 with a subsequent update being released in July 25th of that year." - Anonymous Online Contributor