Clinical trial NCT03758222: Safety and Feasibility of the XFLO Expander System (Mercury)
Official title: A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: MedeonBio, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 45
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from Unanticipated adverse device effects (UADEs)
timeFrame: 1 month (Arm-1)
measure: Freedom from Unanticipated adverse device effects (UADEs)
timeFrame: 6 months (Arm-2)
Secondary outcomes:
measure: Freedom from Unanticipated adverse device effects (UADEs)
timeFrame: 7 months (Arm-1)
measure: Freedom from Unanticipated adverse device effects (UADEs)
timeFrame: 12 months (Arm-2)
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: 1 month and 7 months (Arm-1)
measure: Change in International Prostate Symptom Score (IPSS)
timeFrame: 6 and 12 months (Arm-2)
Other outcomes:
Locations:
city: Wahroonga
country: Australia
facility: Australian Clinical Trials Pty Ltd
state: New South Wales
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: Brunswick Medical Center
city: Tbilisi
country: Georgia
facility: National Center of Urology
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Australian Clinical Trials Pty Ltd
name: Henry Woo, MD
role: PRINCIPAL_INVESTIGATOR
References: