XFLO Expander System for Enlarged Prostate

(EXPANDER-1 Trial)

Recruiting at 4 trial locations

Overseen By Joyce T. Su, MPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: MedeonBio, Inc.

Must be taking: 5-alpha-reductase inhibitors, Alpha-blockers

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Previous BPH procedure, UTI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1, 6, or 12 months

45 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Mercury Expander system, which aims to help men who have trouble urinating because of an enlarged prostate. The device works by opening up the blocked area in the urinary tract, making it easier for urine to pass through. The Mercury Expander System is a novel implantable device designed to treat lower urinary tract symptoms due to benign prostatic hyperplasia.

Will I have to stop taking my current medications?

If you are on BPH-related medications, you must have been on 5-alpha-reductase inhibitors for at least 3 months or alpha-blockers for at least 3 weeks with a stable voiding pattern. The protocol does not specify about other medications, but you should discuss your current medications with the trial team.

What data supports the effectiveness of the XFLO Expander System treatment for enlarged prostate?

The research on balloon dilatation for prostatic obstruction suggests that similar mechanical approaches can improve urinary flow in some patients with benign prostatic hypertrophy (BPH), although results may vary. This indicates that treatments like the XFLO Expander System, which also aim to relieve urinary obstruction, might offer benefits for some patients. ^{1 2 3 4 5}

Research Team

Henry Woo, MD

Principal Investigator

Australian Clinical Trials Pty Ltd

Eligibility Criteria

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.

Inclusion Criteria

I haven't taken medication for an enlarged prostate in the last 6 months.

I am 50 years old or older.

Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound)

Exclusion Criteria

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.

Life expectancy of less than 24 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the XFLO Expander System implantation for 1, 6, or 12 months, depending on the assigned arm

1, 6, or 12 months

Follow-up

Participants are monitored for safety and effectiveness after device retrieval

6 months

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness, including assessment of adverse device effects

12 months

Treatment Details

Interventions

• XFLO Expander System (Mercury)

Trial Overview 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.

Participant Groups

Group I: Arm-3: Device implantation for 12 months Experimental Treatment 1 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 months Experimental Treatment 1 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 month Experimental Treatment 1 Intervention

Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

Who Is Running the Clinical Trial?

MedeonBio, Inc.

Lead Sponsor

Trials

1

Recruited

50+

References

1. United States pubmed.ncbi.nlm.nih.gov

Monocenter Experience with 532 Nm-Laser Photoselective-Vaporization of the Prostate by GreenLight XPS™ Laser: Is It Really an Endourological Joker Card? [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Balloon dilatation for prostatic obstruction. Long-term follow-up. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Hyperlipidemia patients with long-term statin treatment are associated with a reduced risk of progression of benign prostatic enlargement. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Prostate cancer in a large prostate is associated with a decreased prostate specific antigen failure rate after brachytherapy. [2016]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Drug treatments for lower urinary tract symptoms secondary to bladder outflow obstruction: focus on quality of life. [2018]