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Verified

Device: The ProVee Urethral Expander System for Benign Prostatic Hyperplasia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Avant Concierge Urology, Winter Garden, FLVerifiedBenign Prostatic HyperplasiaProVee Urethral Expander System - Device
Eligibility
18+
Male
What conditions do you have?
Select

Study Summary

This trial is studying a device to treat urinary obstruction caused by an enlarged prostate.

Eligible Conditions
  • Benign Prostatic Hyperplasia (BPH)

Treatment Effectiveness

Effectiveness Progress

1 of 3

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GIE Medical ProTractX3 TTS DCB
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Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Procedure - 12 months

Month 12
Safety: Need for urinary catheterization
Procedure - 12 months
Safety: Device or Procedure Related Serious Adverse Events
Procedure to 12 months
Effectiveness: Symptoms Improvement
Procedure to 3 months
Placebos

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Active
3
GIE Medical ProTractX3 TTS DCB
2
Perivascular dexamethasone

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

Device: The ProVee Urethral Expander System
Device
ActiveComparator Group · 1 Intervention: ProVee Urethral Expander System · Intervention Types: Device
Sham: Ureteroscope and urethral access sheath
Procedure
ShamComparator Group · 1 Intervention: Urethral Access Sheath · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: procedure - 12 months

Who is running the clinical trial?

ProVerum MedicalLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Male Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to live in the zip code that you provided full-time.
You should answer yes only if you have never had prostate or bladder cancer.
You have been diagnosed with an enlarged prostate.
Have you had any urinary stones or blood in your urine in the past 3 months? If you answer yes, you may not be eligible.
Have you taken medications like Proscar, Avodart or Jalyn to help you urinate more easily? (Answer "no" if you haven't taken them.)
Have you ever had any medical procedures done on your prostate? If the answer is no, then you meet this criterion.

Who else is applying?

What state do they live in?
Florida53.7%
Nevada43.5%
Texas0.7%
Other2.0%
How old are they?
65+100.0%
What site did they apply to?
Sheldon Freedman MD45.5%
Avant Concierge Urology54.5%
What portion of applicants met pre-screening criteria?
Did not meet criteria43.4%
Met criteria56.6%
How many prior treatments have patients received?
071.0%
116.1%
29.7%
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
Email4.1%
Phone Call95.9%
Most responsive sites:
  1. Sheldon Freedman MD: < 24 hours
  2. Avant Concierge Urology: < 24 hours
Average response time
  • < 2 Days
References

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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