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

MedeonBio

Status: Active, not recruiting

Conditions: Benign Prostatic Hyperplasia

Treatments: Device: XFLO Expander System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03758222

10-CIP-1164

PN-7585,-7998 10-MSC-1082 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 45 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 3 patient groups

Arm-1: Device implantation for 1 month

Experimental group

Description:

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

Treatment:

Device: XFLO Expander System

Arm-2: Device implantation for 6 months

Experimental group

Description:

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

Treatment:

Device: XFLO Expander System

Arm-3: Device implantation for 12 months

Experimental group

Description:

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

Treatment:

Device: XFLO Expander System