Status:
ACTIVE_NOT_RECRUITING
Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath
Lead Sponsor:
Prodeon Medical, Inc
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45+ years
Phase:
NA
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
Eligibility Criteria
Inclusion
- Subject has signed an informed consent form (ICF).
- Men ≥ 45 years.
- 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.
- Prostate volume 30-80 cc measured by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) within 6 months prior to randomization.
- 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.
Exclusion
- Subjects who meet ANY of the following exclusion criteria will not participate in the trial:
- 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).
- Obstructive protruding (mobile) middle (median) prostatic lobe as confirmed by cystoscopy.
- High bladder neck as determined by the Investigator.
- Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
- Biopsy of the prostate within past 8 weeks.
- 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).
- Confirmed or suspected bladder cancer.
- History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
- History of neurogenic bladder.
- Previous episode of AUR, i.e., post hernia repair or other condition or disease that might cause urinary retention.
- Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
- Serum creatinine \> 1.8 mg/dL or renal dysfunction attributed to bladder outlet obstruction (BOO).
- 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).
- Active infection including acute bacterial prostatitis.
- Previous pelvic irradiation or radical pelvic surgery.
- Known allergy to nickel.
- Subjects with life-threatening disease in which life expectancy is foreshortened are excluded.
- Desire to maintain fertility post-treatment.
- Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant).
- Prostatic urethral length \< 25 mm or \> 60 mm, as measured from bladder neck to verumontanum, using cystoscopy just prior to randomization.
- 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).
- 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.
- Unable or unwilling to complete all required questionnaires and follow-up assessments.
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
- 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).
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05400980
Start Date
July 5 2022
End Date
December 1 2028
Last Update
April 9 2025
Active Locations (2)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153
2
Virginia Tech-Carilion School of Medicine
Roanoke, Virginia, United States, 24016