Safety and Feasibility of the XFLO Expander System (Mercury)

NCT ID: NCT03758222

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-07
• Study Completion Date: 2025-08-31

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).

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm-1: Device implantation for 1 month

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

Group Type: EXPERIMENTAL

XFLO Expander System

Intervention Type: DEVICE

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

Arm-2: Device implantation for 6 months

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

Group Type: EXPERIMENTAL

XFLO Expander System

Intervention Type: DEVICE

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

Arm-3: Device implantation for 12 months

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

Group Type: EXPERIMENTAL

XFLO Expander System

Intervention Type: DEVICE

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

Interventions

XFLO Expander System

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

Intervention Type: DEVICE

Other Intervention Names

Mercury

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

MedeonBio, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henry Woo, MD

Role: PRINCIPAL_INVESTIGATOR

Australian Clinical Trials Pty Ltd

Locations

Australian Clinical Trials Pty Ltd

Wahroonga, New South Wales, Australia

University Health Network

Toronto, Ontario, Canada

Brunswick Medical Center

Montreal, , Canada

National Center of Urology

Tbilisi, , Georgia

China Medical University Hospital

Taichung, , Taiwan

Countries

Australia; Canada; Georgia; Taiwan

Other Identifiers

PN-7585,-7998 10-MSC-1082

Identifier Type: OTHER

Identifier Source: secondary_id

10-CIP-1164

Identifier Type: -

Identifier Source: org_study_id