Safety and Feasibility of the XFLO Expander System (Mercury)

Benign Prostatic Hyperplasia Clinical Trial

— EXPANDER-1  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03758222
• Other study ID #: 10-CIP-1164
• Secondary ID: PN-7585,-7998 10
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: August 2025

Study information

• Verified date: July 2022
• Source: MedeonBio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: August 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Australia	Australian Clinical Trials Pty Ltd	Wahroonga	New South Wales
Canada	Brunswick Medical Center	Montréal
Canada	University Health Network	Toronto	Ontario
Georgia	National Center of Urology	Tbilisi
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
MedeonBio, Inc.

Countries where clinical trial is conducted

Australia,  Canada,  Georgia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from Unanticipated adverse device effects (UADEs)	Measure any device or procedure related adverse events	1 month (Arm-1)
Primary	Freedom from Unanticipated adverse device effects (UADEs)	Measure any device or procedure related adverse events	6 months (Arm-2)
Secondary	Freedom from Unanticipated adverse device effects (UADEs)	Measure any device or procedure related adverse events	7 months (Arm-1)
Secondary	Freedom from Unanticipated adverse device effects (UADEs)	Measure any device or procedure related adverse events	12 months (Arm-2)
Secondary	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)
Secondary	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)