Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath
- Conditions
- Benign Prostatic Hyperplasia
- Registration Number
- NCT05400980
- Lead Sponsor
- Prodeon Medical, Inc
- Brief Summary
To demonstrate the safety and efficacy of the Urocross Expander System/Retrieval Sheath and the procedure to treat patients with symptomatic Benign Prostatic Hyperplasia (BPH).
- Detailed Description
Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 240
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Subject has signed an informed consent form (ICF).
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Men ≥ 45 years.
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Symptomatic BPH with the following (all must be met):
- IPSS ≥ 13.
- Qmax ≤ 12 mL/sec on a voided volume of ≥ 125 mL.
- PVR < 250 mL.
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Prostate volume 30-80 cc measured by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) within 6 months prior to randomization.
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Subjects willing to be off their BPH-related medications from time of enrollment and throughout study participation.
Note: All subjects on BPH-related medications must start a washout period prior to qualifying questionnaires and uroflowmetry.
Subjects who meet ANY of the following exclusion criteria will not participate in the trial:
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Previous BPH procedure intended to disobstruct the bladder outlet (e.g., prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate).
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Obstructive protruding (mobile) middle (median) prostatic lobe as confirmed by cystoscopy.
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High bladder neck as determined by the Investigator.
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Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
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Biopsy of the prostate within past 8 weeks.
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Baseline Prostate Specific Antigen (PSA) level > 10 ng/mL or confirmed or suspected prostate cancer (subjects with a PSA level > 2.5 ng/mL or whose PSA levels fall outside age-specific or local reference ranges, should have prostate cancer excluded to the Investigator's satisfaction in conjunction with shared decision making [SDM] with the study subjects).
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Confirmed or suspected bladder cancer.
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History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
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History of neurogenic bladder.
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Previous episode of AUR, i.e., post hernia repair or other condition or disease that might cause urinary retention.
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Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
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Serum creatinine > 1.8 mg/dL or renal dysfunction attributed to bladder outlet obstruction (BOO).
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Concomitant UTI (subject can be enrolled following successful treatment of UTI and a negative UTI test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months).
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Active infection including acute bacterial prostatitis.
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Previous pelvic irradiation or radical pelvic surgery.
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Known allergy to nickel.
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Subjects with life-threatening disease in which life expectancy is foreshortened are excluded.
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Desire to maintain fertility post-treatment.
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Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant).
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Prostatic urethral length < 25 mm or > 60 mm, as measured from bladder neck to verumontanum, using cystoscopy just prior to randomization.
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Any concurrent medical condition or illness that might prevent study completion or that could impact the study results such as:
- severe cardiac arrhythmias uncontrolled by medications or pacemaker.
- congestive heart failure New York Heart Association (NYHA) III or IV.
- uncontrolled diabetes mellitus.
- significant respiratory disease in which hospitalization may be required.
- known immunosuppression (i.e., AIDS, post-transplant, undergoing chemotherapy).
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Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure.
Note: Low dose aspirin therapy is acceptable.
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Unable or unwilling to complete all required questionnaires and follow-up assessments.
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Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
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Subject is in custody or institution, or, in the Investigator's opinion, has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety of Urocross Expander Implant more than 7 days post procedure The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void.
Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath 3 months post-procedure The primary efficacy endpoint is Change from Baseline in Total International Prostate Symptom Score (IPSS) at 3 months post-procedure. The IPSS items range in score from 0-5, with higher scores indicating worse symptoms. The study is powered to show that the average improvement in Total IPSS among the Urocross Implant subjects is more than 25% greater than the average improvement in Total IPSS among the sham-control subjects.
- Secondary Outcome Measures
Name Time Method Percent change in Total IPSS for subjects randomized to the Urocross Implant 3 months post-procedure The major secondary efficacy endpoint is the percent change in Total IPSS from baseline (i.e., pre-procedure) to 3 months post-procedure for subjects randomized to the Urocross Implant group. The IPSS items range in score from 0-5, with higher scores indicating worse symptoms.
Trial Locations
- Locations (2)
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Virginia Tech-Carilion School of Medicine
🇺🇸Roanoke, Virginia, United States
Loyola University Medical Center🇺🇸Maywood, Illinois, United States