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

A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: XFLO Expander System

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Wahroonga, New South Wales, Australia, 2076
      • Australian Clinical Trials Pty Ltd
• Canada
  • Montréal, Canada
    • Brunswick Medical Center
  • Ontario
    • Toronto, Ontario, Canada
      • University Health Network
• Georgia
  • Tbilisi, Georgia, 0144
    • National Center of Urology
• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm-1: Device implantation for 1 month; Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.	Device: XFLO Expander System; Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH); Other Names: Mercury
EXPERIMENTAL: Arm-2: Device implantation for 6 months; Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.	Device: XFLO Expander System; Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH); Other Names: Mercury
EXPERIMENTAL: Arm-3: Device implantation for 12 months; Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.	Device: XFLO Expander System; Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH); Other Names: Mercury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Unanticipated adverse device effects (UADEs)	Measure any device or procedure related adverse events	1 month (Arm-1)
Freedom from Unanticipated adverse device effects (UADEs)	Measure any device or procedure related adverse events	6 months (Arm-2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from Unanticipated adverse device effects (UADEs)	Measure any device or procedure related adverse events	7 months (Arm-1)
Freedom from Unanticipated adverse device effects (UADEs)	Measure any device or procedure related adverse events	12 months (Arm-2)
Change in International Prostate Symptom Score (IPSS)	Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)	1 month and 7 months (Arm-1)
Change in International Prostate Symptom Score (IPSS)	Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)	6 and 12 months (Arm-2)

Collaborators and Investigators

• Sponsor: MedeonBio, Inc.
• Investigators: Principal Investigator: Henry Woo, MD, Australian Clinical Trials Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2018
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): August 1, 2025

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: 10-CIP-1164; PN-7585,-7998 10-MSC-1082 (OTHER: Prodeon Medical, Inc.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes