Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-05

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Investigating Medication vs. Prostatic Urethral Lift: Assessment and Comparison of Therapies for BPH

NCT04987892

BPH

RECRUITING PHASE4

A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

NCT06849258

Benign Prostatic Hyperplasia

RECRUITING NA

Study of Median Lobe Prostatic UroLift Procedure

NCT02625545

Benign Prostatic Hyperplasia (BPH)

COMPLETED NA

Prostatic Artery Embolization (PAE) for Treatment of Benign Prostatic Hyperplasia (BPH)

NCT02026908

Benign Prostatic Hyperplasia (BPH)

COMPLETED NA

Safety and Feasibility of the XFLO Expander System (Mercury)

NCT03758222

Benign Prostatic Hyperplasia

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Benign Prostatic Hyperplasia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

All subjects will be blinded to the treatment assignment up to the primary efficacy endpoint (3 months post-procedure).

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Urocross implant group

The investigational products in this trial are the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath used to retrieve the implant after 6 months following its implant.

Group Type EXPERIMENTAL

Urocross implant

Intervention Type DEVICE

Urocross implant inserted via delivery catheter

Sham-control group

The sham-control in this trial is cystoscopy only.

Group Type SHAM_COMPARATOR

Sham-control

Intervention Type DIAGNOSTIC_TEST

Cystoscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Urocross implant

Urocross implant inserted via delivery catheter

Intervention Type DEVICE

Sham-control

Cystoscopy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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).

Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No