Clinical trial NCT05400980: Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath
Official title: The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross® Expander System and Retrieval Sheath
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Keywords: Prostate
BPH
Benign
Minimally Invasive
Temporary
Lead sponsor: Prodeon Medical, Inc
Sponsor class: INDUSTRY
First posted: 2022-06-02
Enrollment: 240
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)
Primary purpose: TREATMENT

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 Criteria:

1. Subject has signed an informed consent form (ICF).
2. Men ≥ 45 years.
3. 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.
4. Prostate volume 30-80 cc measured by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) within 6 months prior to randomization.
5. 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 Criteria:

Subjects who meet ANY of the following exclusion criteria will not participate in the trial:

1. 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).
2. Obstructive protruding (mobile) middle (median) prostatic lobe as confirmed by cystoscopy.
3. High bladder neck as determined by the Investigator.
4. Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
5. Biopsy of the prostate within past 8 weeks.
6. 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).
7. Confirmed or suspected bladder cancer.
8. History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
9. History of neurogenic bladder.
10. Previous episode of AUR, i.e., post hernia repair or other condition or disease that might cause urinary retention.
11. Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
12. Serum creatinine \> 1.8 mg/dL or renal dysfunction attributed to bladder outlet obstruction (BOO).
13. 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).
14. Active infection including acute bacterial prostatitis.
15. Previous pelvic irradiation or radical pelvic surgery.
16. Known allergy to nickel.
17. Subjects with life-threatening disease in which life expectancy is foreshortened are excluded.
18. Desire to maintain fertility post-treatment.
19. Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant).
20. Prostatic urethral length \< 25 mm or \> 60 mm, as measured from bladder neck to verumontanum, using cystoscopy just prior to randomization.
21. 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).
22. 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.
23. Unable or unwilling to complete all required questionnaires and follow-up assessments.
24. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
25. 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).

Primary outcomes:
measure: Safety of Urocross Expander Implant
timeFrame: more than 7 days post procedure
measure: Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath
timeFrame: 3 months post-procedure
Secondary outcomes:
measure: Percent change in Total IPSS for subjects randomized to the Urocross Implant
timeFrame: 3 months post-procedure
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Roanoke
country: United States
facility: Virginia Tech-Carilion School of Medicine
state: Virginia
Study officials:
affiliation: Loyola University
name: Kevin T. McVary
role: PRINCIPAL_INVESTIGATOR
affiliation: Carilion Clinic
name: Daniel B. Rukstalis
role: PRINCIPAL_INVESTIGATOR
References: