The Expander-2 Trial: A Randomized Study to Evaluate the Safety and Efficacy of the Urocross(TM) Expander System and Retrieval Sheath
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|ClinicalTrials.gov Identifier: NCT05400980|
Recruitment Status : Recruiting
First Posted : June 2, 2022
Last Update Posted : May 10, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Benign Prostatic Hyperplasia||Device: Urocross implant Diagnostic Test: Sham-control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|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).|
|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|
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
- 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.
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||45 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
Subjects who meet ANY of the following exclusion criteria will not participate in the trial:
- Previous BPH procedure intended to disobstruct the bladder outlet.
- Obstructive protruding (mobile) middle (median) prostatic lobe.
- High bladder neck.
- 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.
- Confirmed or suspected bladder cancer.
- 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).
- History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
- History of neurogenic bladder.
- Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
- Previous episode of Acute Urinary Retention (AUR) i.e., post hernia repair or other condition or disease that might cause urinary retention.
- Serum creatinine > 1.8 mg/dl or renal dysfunction attributed to bladder outlet obstruction (BOO).
- 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).
- Active infection including acute bacterial prostatitis.
- Previous pelvic irradiation or radical pelvic surgery.
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
|Contact: Clinical Departmentemail@example.com|
|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 firstname.lastname@example.org|
|United States, South Carolina|
|Prisma Health||Not yet recruiting|
|Columbia, South Carolina, United States, 29203|
|Contact: Daniel B. Rukstalis 803-434-3109 email@example.com|
|Principal Investigator:||Kevin T. McVary||Loyola University|
|Principal Investigator:||Daniel B. Rukstalis||Prisma Health|
|Responsible Party:||Prodeon Medical, Inc|
|Other Study ID Numbers:||
|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|
|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|
Genital Diseases, Male
Male Urogenital Diseases