Safety and Feasibility of the XFLO Expander System (Mercury) (EXPANDER-1)

  • STATUS
    Recruiting
  • End date
    Jul 17, 2025
  • participants needed
    70
  • sponsor
    MedeonBio, Inc.
Updated on 1 February 2022
obstruction
transrectal ultrasound
benign prostatic hypertrophy
lower urinary tract symptoms
rectal ultrasound
cystoscopy
benign prostatic hyperplasia
hyperplasia

Summary

To demonstrate the safety and feasibility of the Mercury Expander system and procedure to treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia.

Description

A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the Mercury Expander system in patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia (BPH).

Details
Condition Benign Prostatic Hyperplasia
Treatment Mercury Expander System, XFLO Expander System
Clinical Study IdentifierNCT03758222
SponsorMedeonBio, Inc.
Last Modified on1 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male gender
Age 50 years
Prostate volume 30 - 80 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound (TRUS)
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)
Medication history
Not on BPH related medication for the past 6 months
If on BPH related medication
On 5-alpha-reductase inhibitors (ARIs), the patient must be on the medication for at least 3 months with a stable voiding pattern
On alpha-blockers, the patient must be on the medication for at least 3 weeks with a stable voiding pattern
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

Exclusion Criteria

Previous BPH procedure
Median prostatic lobe or high bladder neck
Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
Elevated Prostate Specific Antigen (PSA) 10 ng/mL unless negative biopsy within last 6 months, or a positive biopsy showing cancer
Cystolithiasis within the prior 3 months
History of neurogenic bladder or urinary retention with PVR >1000mL
Serum creatinine >1.8 mg/dl or upper-tract disease which compromises renal function
Current or recent Urinary Tract Infection (UTI) or disease
Known allergy to nickel
Life expectancy of less than 24 months
Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
Anticipated need for additional surgery or treatments for comorbidities during the study period
Current gross hematuria
Other co-morbidities that could impact the study results
Unable or unwilling to complete all required questionnaires and follow-up assessments
Unable or unwilling to sign informed consent form
Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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