Safety and Feasibility of the XFLO Expander System (Mercury)

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Benign Prostatic Hyperplasia

Intervention / Treatment
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* Device: XFLO Expander System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) |