Safety and Feasibility of the XFLO Expander System (Mercury)

Not Applicable

Active, not recruiting

• Conditions: Benign Prostatic Hyperplasia
• Interventions: Device: XFLO Expander System

• Registration Number: NCT03758222
• Lead Sponsor: MedeonBio, Inc.

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).

Study Timeline

• Study Start: 2018-11-07
• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26
• Primary Completion: 2022-12
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm-3: Device implantation for 12 months	XFLO Expander System	Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.
Arm-2: Device implantation for 6 months	XFLO Expander System	Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.
Arm-1: Device implantation for 1 month	XFLO Expander System	Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

Primary Outcome Measures

Name	Time	Method
Freedom from Unanticipated adverse device effects (UADEs)	6 months (Arm-2)	Measure any device or procedure related adverse events

Secondary Outcome Measures

Name	Time	Method
Freedom from Unanticipated adverse device effects (UADEs)	12 months (Arm-2)	Measure any device or procedure related adverse events
Change in International Prostate Symptom Score (IPSS)	6 and 12 months (Arm-2)	Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)

Trial Locations

Locations (5)

National Center of Urology; 🇬🇪 Tbilisi, Georgia

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Australian Clinical Trials Pty Ltd; 🇦🇺 Wahroonga, New South Wales, Australia

Brunswick Medical Center; 🇨🇦 Montréal, Canada