XFLO Expander System for Enlarged Prostate
(EXPANDER-1 Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Dr. Henry H. Woo, MD | Manhasset, NY ...

Overseen byHenry Woo, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: MedeonBio, Inc.

No Placebo Group

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.

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)

+4 more

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

+14 more

Participant Groups

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.

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.