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Procedure

ProVee Device for Enlarged Prostate

N/A

Waitlist Available

Research Sponsored by ProVerum Medical

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

Must not have

Neurogenic bladder and/or sphincter abnormalities due to Parkinson's disease, multiple sclerosis, cerebral vascular accident, diabetes

Use of estrogen or drug-producing androgen suppression (e.g. gonadotropin-releasing hormonal analogues) within 1 year of baseline assessment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up (time frame: procedure to 3 months)

Awards & highlights

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.

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).

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 below

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I am a man older than 45.

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My prostate size is between 30 cc and 80 cc.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have bladder control issues due to a neurological condition.

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I have used hormone therapy within the last year.

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My diabetes is not under control, with Hgb A1C over 8%.

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I am on medication for an overactive bladder.

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I am currently taking tri-cyclic antidepressants.

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My kidney function is not normal.

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My prostate has a significant obstruction due to a median lobe issue.

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My condition suggests a primary blockage at the bladder entrance without side growths.

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My anatomy allows for proper medical device placement.

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I am currently unable to urinate.

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I have or might have had prostate or bladder cancer.

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I have had prostatitis in the last two years.

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I currently have a urinary tract infection.

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I have had rectal surgery before, but not for hemorrhoids.

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I have a narrowed urethra or other bladder issues.

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I have had surgery or other invasive treatments on my prostate.

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I have had radiation or major surgery in my pelvic area.

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I experience involuntary loss of urine.

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I do not have any severe health issues that could interfere with the study.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and (time frame: procedure to 3 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

0 / 21Eligibility criteria met

Find a Location

Who is running the clinical trial?

ProVerum MedicalLead Sponsor

2 Previous Clinical Trials

235 Total Patients Enrolled

~0 spots leftby Sep 2024

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