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Prostate Implant
Urocross Expander System for Enlarged Prostate
N/A
Recruiting
Led By Kevin T. McVary
Research Sponsored by Prodeon Medical, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptomatic BPH with the following (all must be met):
Subjects must be willing to be off their BPH-related medications from time of enrollment and throughout the study. Note: All subjects on BPH-related medications must start a washout period prior to randomization on the procedure day.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month post implant retrieval
Awards & highlights
Study Summary
This trial is testing a new system and procedure to treat patients with BPH. The goal is to show that it is safe and effective.
Who is the study for?
Men aged 45 or older with symptomatic Benign Prostatic Hyperplasia (BPH), having a prostate size of 30-80 cc, and experiencing reduced urine flow. Participants must not be on BPH medications during the trial and should have no history of certain neurological diseases, prior prostate surgeries, or conditions like urethral strictures that could affect bladder function.Check my eligibility
What is being tested?
The Expander-2 Trial is testing the Urocross Expander System/Retrieval Sheath against a sham-control to treat symptoms of an enlarged prostate. Men will be randomly assigned to receive either the actual device implantation or a simulated procedure without therapeutic effect.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort at the implant site, potential urinary issues such as infection or irritation, bleeding, and possibly temporary difficulty with urination post-procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms from an enlarged prostate.
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I agree to stop my BPH medications for the study.
Select...
I am a man aged 45 or older.
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My prostate size is between 30 and 80 cc.
Select...
I am a man aged 45 or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month post implant retrieval
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month post implant retrieval
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath
Safety of Urocross Expander Implant
Secondary outcome measures
Percent change in Total IPSS
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Urocross implant groupExperimental Treatment1 Intervention
The investigational products in this trial are the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath used to retrieve the implant after 6 months following its implant.
Group II: Sham-control groupPlacebo Group1 Intervention
The sham-control in this trial is cystoscopy only.
Find a Location
Who is running the clinical trial?
Prodeon Medical, IncLead Sponsor
Kevin T. McVaryPrincipal InvestigatorLoyola University
1 Previous Clinical Trials
3,407 Total Patients Enrolled
Daniel B. RukstalisPrincipal InvestigatorPrisma Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms from an enlarged prostate.My prostate size is between 30 and 80 cc.I agree to stop my BPH medications for the study.I have had an episode of not being able to urinate due to a condition or surgery.I am a man aged 45 or older.I have had a procedure to improve urine flow from my bladder.I have had issues with narrowing in my urinary tract needing multiple treatments.I have a neurological condition like Parkinson's that affects my bladder.I have a history of bladder control issues due to nerve problems.I have a growing middle part of the prostate.I had a UTI but it's treated now, or I've had 2 or more UTIs in the past year.I have or might have prostate cancer, with specific PSA levels that required a biopsy.My prostate size is between 30 and 80 cc.My kidney function is impaired, with creatinine over 1.8 mg/dl or due to bladder obstruction.I am a man aged 45 or older.I do not have any active infections, including prostate infections.I have had radiation or major surgery in my pelvic area.You have IPSS ≥ 13.My bladder neck is higher than usual.I have been diagnosed with or suspected to have bladder cancer.I have not had kidney stones or kidney disease in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Sham-control group
- Group 2: Urocross implant group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any US health facilities that are executing this experiment?
"A total of 6 clinical trial sites are available for this medical research. The locations include David Nudell in San Jose, Urology Associates of Silicon Valley in New york, and Columbia University Medical Center in Maywood; with an additional 3 sites also taking part."
Answered by AI
Are there currently opportunities for people to participate in this experiment?
"According to clinicaltrials.gov, this research project is actively recruiting participants since its initial posting on July 5th 2022 and most recent amendment on October 19th 2022."
Answered by AI
How many participants are included in this research endeavor?
"Affirmative. Clinicaltrials.gov exhibits that the trial, first posted on July 5th 2022, is presently enrolling participants. This clinical study seeks to recruit 240 individuals from 6 sites."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
British Columbia
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Loyola University Medical Center
Urology Associates of Silicon Valley
Sheldon Freedman
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have tried 3 other drugs that help but do not cure the problem.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- Sheldon Freedman: < 24 hours
Average response time
- < 1 Day
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