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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males > 45 years of age
Prostate volume of ≥ 30 cc and ≤ 80 cc
Timeline
Screening 3 weeks
Treatment Varies
Follow Up (time frame: procedure to 3 months)
Awards & highlights
Study Summary
This trial is testing a new system for treating urinary obstruction in men with an enlarged prostate to see how well it works.
Who is the study for?
This trial is for men over 45 with bothersome urinary symptoms due to an enlarged prostate, who have not had success with or cannot take medications for these symptoms. They should have a certain level of symptom severity and prostate size.Check my eligibility
What is being tested?
The ProVIDE II study is testing the Generation II delivery system's ability to place the ProVee expander in patients suffering from urinary blockage caused by an enlarged prostate (BPH).See study design
What are the potential side effects?
While specific side effects are not listed, procedures involving devices like the ProVee expander may include discomfort, infection risk at the site of insertion, bleeding, or potential worsening of urinary symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man older than 45.
Select...
My prostate size is between 30 cc and 80 cc.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ (time frame: procedure to 3 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~(time frame: procedure to 3 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Need for urinary catheterization
Serious Adverse Events
Technical Success
Trial Design
1Treatment groups
Experimental Treatment
Group I: ProVee treatmentExperimental Treatment1 Intervention
ProVee Expander is placed in prostatic urethra to relieve obstruction due to BPH.
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Who is running the clinical trial?
ProVerum MedicalLead Sponsor
2 Previous Clinical Trials
235 Total Patients Enrolled
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