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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05400980
Recruitment Status : Recruiting
First Posted : June 2, 2022
Last Update Posted : May 10, 2023
Sponsor:
Information provided by (Responsible Party):
Prodeon Medical, Inc

Study Description
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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).

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Urocross implant Diagnostic Test: Sham-control Not Applicable

Detailed Description:
Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)
Masking: Double (Participant, Outcomes Assessor)
Masking Description: All subjects will be blinded to the treatment assignment up to the primary efficacy endpoint (3 months post-procedure).
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 5, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : January 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Urocross Expander Implant [ Time Frame: more than 7 days post procedure ]
    The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void.

  2. Efficacy of the Urocross Expander Implant as delivered by the Urocross Expander System and the Urocross Retrieval Sheath [ Time Frame: 3 month post procedure ]
    Mean improvement in Total IPSS at 3 months vs baseline


Secondary Outcome Measures :
  1. Percent change in Total IPSS [ Time Frame: 12 Month post implant retrieval ]
    Percent change in Total IPSS from baseline to 12 months post-retrieval for subjects randomized to the Urocross Implant group


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05400980


Contacts
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Contact: Clinical Department 6694671100 clinical@prodeonmedical.com

Locations
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United States, California
Urology Associates of Silicon Valley Recruiting
San Jose, California, United States, 95124
Contact: Leena Awni         
United States, Illinois
Loyola University Medical Center Not yet recruiting
Maywood, Illinois, United States, 60153
Contact: Kevin T. McVary    708-216-0291    kmcvary@gmail.com   
United States, South Carolina
Prisma Health Not yet recruiting
Columbia, South Carolina, United States, 29203
Contact: Daniel B. Rukstalis    803-434-3109    dbrukstalis@me.com   
Sponsors and Collaborators
Prodeon Medical, Inc
Investigators
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Principal Investigator: Kevin T. McVary Loyola University
Principal Investigator: Daniel B. Rukstalis Prisma Health
More Information
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Responsible Party: Prodeon Medical, Inc
ClinicalTrials.gov Identifier: NCT05400980    
Other Study ID Numbers: CP002
First Posted: June 2, 2022    Key Record Dates
Last Update Posted: May 10, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Prodeon Medical, Inc:
Prostate
BPH
Benign
Minimally Invasive
Temporary
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases