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

NCT05400980 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP002
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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).

Conditions

Benign Prostatic Hyperplasia

Keywords

Prostate; BPH; Benign; Minimally Invasive; Temporary

Outcome Measures

Primary Outcomes (2)

• Safety of Urocross Expander Implant

  The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void.

  more than 7 days post procedure

• Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath

  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.

  3 months post-procedure

Secondary Outcomes (1)

• Percent change in Total IPSS for subjects randomized to the Urocross Implant

  3 months post-procedure

Study Arms (2)

Urocross implant group

EXPERIMENTAL

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.

Device: Urocross implant

Sham-control group

SHAM COMPARATOR

The sham-control in this trial is cystoscopy only.

Diagnostic Test: Sham-control

Interventions

Urocross implant DEVICE

Urocross implant inserted via delivery catheter

Urocross implant group

Sham-control DIAGNOSTIC_TEST

Cystoscopy

Sham-control group

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prodeon Medical, Inc: lead

Study Sites (2)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Virginia Tech-Carilion School of Medicine

Roanoke, Virginia, 24016, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Kevin T. McVary

  Loyola University

  PRINCIPAL INVESTIGATOR

• Daniel B. Rukstalis

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All subjects will be blinded to the treatment assignment up to the primary efficacy endpoint (3 months post-procedure).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 2, 2022
• Study Start: July 5, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)