The Expander-2 Trial: A Randomized Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath

The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath

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).

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Device: Urocross implant; Diagnostic test: Sham-control

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Department; Phone Number: 6694671100; Email: clinical@prodeonmedical.com

Study Locations

• United States
  • California
    • San Jose, California, United States, 95124
      • Recruiting
      • Urology Associates of Silicon Valley
      • Contact: Leena Awni
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Not yet recruiting
      • Loyola University Medical Center
      • Contact: Kevin T. McVary; Phone Number: 708-216-0291; Email: kmcvary@gmail.com
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Not yet recruiting
      • Prisma Health
      • Contact: Daniel B. Rukstalis; Phone Number: 803-434-3109; Email: dbrukstalis@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.
5. Subjects must be willing to be off their BPH-related medications from time of enrollment and throughout the study. Note: All subjects on BPH-related medications must start a washout period prior to randomization on the procedure day.

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.
2. Obstructive protruding (mobile) middle (median) prostatic lobe.
3. High bladder neck.
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. Confirmed or suspected bladder cancer.
7. Confirmed or suspected prostate cancer. Note: Subjects with suspected prostate cancer with a Prostate Specific Antigen (PSA) level > 2.5 ng/mL and ≤ 10 ng/mL with their free PSA < 25% of total PSA, must undergo a biopsy to rule out the diagnosis of prostate cancer. If biopsy is performed, and subject has no cancer, a waiting period of 8 weeks is required prior to randomization (see exclusion criterion 7).
8. History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
9. History of neurogenic bladder.
10. Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
11. Previous episode of Acute Urinary Retention (AUR) i.e., post hernia repair or other condition or disease that might cause urinary retention.
12. Serum creatinine > 1.8 mg/dl or renal dysfunction attributed to bladder outlet obstruction (BOO).
13. Concomitant Urinary Tract Infection (UTI) (subject can be enrolled following successful treatment of UTI and a negative urine culture), 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Urocross implant; Urocross implant inserted via delivery catheter
Sham Comparator: Sham-control group; The sham-control in this trial is cystoscopy only.	Diagnostic test: Sham-control; Cystoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Mean improvement in Total IPSS at 3 months vs baseline	3 month post procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change in Total IPSS	Percent change in Total IPSS from baseline to 12 months post-retrieval for subjects randomized to the Urocross Implant group	12 Month post implant retrieval

Collaborators and Investigators

• Sponsor: Prodeon Medical, Inc
• Investigators: Principal Investigator: Kevin T. McVary, Loyola University; Principal Investigator: Daniel B. Rukstalis, Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 27, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Prostate; BPH; Benign; Minimally Invasive; Temporary
• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: CP002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes