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Expander System
XFLO Expander System for Enlarged Prostate (EXPANDER-1 Trial)
N/A
Waitlist Available
Led By Henry Woo, MD
Research Sponsored by MedeonBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 50 years
Patients with symptomatic BPH and related lower urinary tract symptoms (LUTS): With International Prostate Symptom Score (IPSS) > 13; Qmax < 12 mL/sec on a voided volume ≥125 mL; Post-void residual (PVR) < 250 mL; QoL score ≥ 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 and 12 months (arm-2)
Awards & highlights
EXPANDER-1 Trial Summary
This trial shows that the Mercury Expander system is safe and effective for treating patients with LUTS from BPH.
Who is the study for?
Men over 50 with benign prostatic hyperplasia (BPH) causing urinary issues, who haven't taken BPH meds in the last 6 months or have a stable pattern on current meds. They should have a prostate size of 30-80 cc and meet specific criteria for urinary flow and symptoms. Excluded are those with other health conditions that could affect results, previous BPH procedures, certain medication use, or allergies to nickel.Check my eligibility
What is being tested?
The trial is testing the XFLO Expander System's safety and ability to treat lower urinary tract symptoms due to BPH. Participants will undergo a procedure using this system to see if it improves their symptoms without causing significant complications.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort at the site of insertion, infection risk from the procedure, possible allergic reactions especially in individuals sensitive to nickel which is part of exclusion criteria.
EXPANDER-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
Select...
I have severe urinary symptoms from an enlarged prostate, with specific test scores.
Select...
I am male.
EXPANDER-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 and 12 months (arm-2)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 and 12 months (arm-2)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change in International Prostate Symptom Score (IPSS)
Freedom from Unanticipated adverse device effects (UADEs)
EXPANDER-1 Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm-3: Device implantation for 12 monthsExperimental Treatment1 Intervention
Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.
Group II: Arm-2: Device implantation for 6 monthsExperimental Treatment1 Intervention
Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.
Group III: Arm-1: Device implantation for 1 monthExperimental Treatment1 Intervention
Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.
Find a Location
Who is running the clinical trial?
MedeonBio, Inc.Lead Sponsor
Henry Woo, MDPrincipal InvestigatorAustralian Clinical Trials Pty Ltd
2 Previous Clinical Trials
167 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken medication for an enlarged prostate in the last 6 months.I expect to need more surgery or treatment for other health issues during the study.I currently have, or recently had, a urinary tract infection.I am 50 years old or older.I have severe urinary symptoms from an enlarged prostate, with specific test scores.I have had bladder stones in the last 3 months.I don't have blood clotting disorders and am not on blood thinners, except for low-dose aspirin.My prostate size is between 30 and 80 cc as measured by ultrasound.I have been on BPH medication for the required time and my symptoms are stable.My prostate or bladder neck is enlarged.I have had issues with narrowing in my urinary tract needing multiple treatments.I have had a procedure for an enlarged prostate.My PSA level is 10 ng/mL or higher, or I had a positive biopsy showing cancer.I have other health conditions that might affect the study.My kidney function is impaired due to high creatinine or upper-tract disease.I am male.I have a history of bladder control issues with significant urine retention.I am currently experiencing blood in my urine.
Research Study Groups:
This trial has the following groups:- Group 1: Arm-1: Device implantation for 1 month
- Group 2: Arm-2: Device implantation for 6 months
- Group 3: Arm-3: Device implantation for 12 months
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 vacancy for participants in this research?
"From what is indicated on clinicaltrials.gov, this particular study is not currently seeking participants. The listing was published on November 7th, 2018 and edited most recently on July 25th, 2022. There are, however, 145 other trials actively recruiting patients."
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