Safety and Feasibility of the XFLO Expander System (Mercury)

NCT03758222 | Unknown FDA Device

• 2 other identifiers: 10-CIP-1164PN-7585,-7998 10-MSC-1082
• Study Type: interventional
• Target: 45
• Locations: 4 countries
• Sites: 5

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Freedom from Unanticipated adverse device effects (UADEs)

  7 months (Arm-1)

• Freedom from Unanticipated adverse device effects (UADEs)

  12 months (Arm-2)

• Change in International Prostate Symptom Score (IPSS)

  1 month and 7 months (Arm-1)

• Change in International Prostate Symptom Score (IPSS)

  6 and 12 months (Arm-2)

Study Arms (3)

Arm-1: Device implantation for 1 month

EXPERIMENTAL

Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

Device: XFLO Expander System

Arm-2: Device implantation for 6 months

EXPERIMENTAL

Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.

Device: XFLO Expander System

Arm-3: Device implantation for 12 months

EXPERIMENTAL

Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.

Device: XFLO Expander System

Interventions

XFLO Expander System DEVICE

Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)

Also known as: Mercury

Arm-1: Device implantation for 1 month; Arm-2: Device implantation for 6 months; Arm-3: Device implantation for 12 months

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Benign prostatic hyperplasia (BPH) is a male disease
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedeonBio, Inc.: lead

Study Sites (5)

Australian Clinical Trials Pty Ltd

Wahroonga, New South Wales, 2076, Australia

Location

University Health Network

Toronto, Ontario, Canada

Location

Brunswick Medical Center

Montreal, Canada

Location

National Center of Urology

Tbilisi, 0144, Georgia

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Henry Woo, MD

  Australian Clinical Trials Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 29, 2018
• Study Start: November 7, 2018
• Primary Completion: December 1, 2022
• Study Completion: August 1, 2025
• Last Updated: July 26, 2022

Record last verified: 2022-07

Locations

AU (1); GE (1); TW (1); CA (2)