Benign Prostatic HyperplasiaNCT05400980
Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath
A study testing Urocross implant in people with Benign Prostatic Hyperplasia, run by Prodeon Medical, Inc at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Urocross implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Jul 2022to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- Subjects who meet ANY of the following exclusion criteria will not participate in the trial:
- 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.
Show all 32Show fewer
- 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.
- Known allergy to nickel.
- Subjects with life-threatening disease in which life expectancy is foreshortened are excluded.
- Desire to maintain fertility post-treatment.
- Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant).
- Prostatic urethral length < 25 mm or > 60 mm, as measured from bladder neck to verumontanum, using cystoscopy just prior to randomization.
- 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).
- 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.
- Unable or unwilling to complete all required questionnaires and follow-up assessments.
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Loyola University Medical Center
Maywood, Illinois, 60153
Virginia Tech-Carilion School of Medicine
Roanoke, Virginia, 24016
About this study
Official title: The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross® 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).
Read the detailed description
Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Urocross implant, Sham-control
- Keywords
- Prostate, BPH, Benign, Minimally Invasive, Temporary
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urocross implantDevice
Urocross implant inserted via delivery catheter
Sham-controlDiagnostic test
Cystoscopy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Urocross implant |
| Sham-control group | Sham comparator | The sham-control in this trial is cystoscopy only. Receives: Diagnostic Test: Sham-control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Urocross Expander Implant
The rate of extended post-operative urinary catheterization (more than 7 days) from treatment for inability to void.
Measured: 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.
Measured: 3 months post-procedure
Secondary outcomes (1)
Percent change in Total IPSS for subjects randomized to the Urocross Implant
The major secondary efficacy endpoint is the percent change in Total IPSS from baseline (i.e., pre-procedure) to 3 months post-procedure for subjects randomized to the Urocross Implant group. The IPSS items range in score from 0-5, with higher scores indicating worse symptoms.
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start5 Jul 2022
- Primary completionJan 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prodeon Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin T. McVary, Principal investigator, Loyola UniversityDaniel B. Rukstalis, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400980
- Sponsor's protocol ID
- CP002
- Status last verified
- Sep 2026
- First submitted
- 27 May 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross® Expander System and Retrieval Sheath
- ClinicalTrials.gov ID
- NCT05400980
- Acronym / sponsor ID
- CP002
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Prostate, BPH, Benign, Minimally Invasive, Temporary
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Prodeon Medical, IncIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization in a ratio 2:1 Urocross Expander implant using the Urocross Expander System vs. Sham control (cystoscopy only)
| Arm | Type | Receives |
|---|---|---|
| Urocross implant group | Experimental | Device: Urocross implantThe 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. |
| Sham-control group | Sham comparator | Diagnostic Test: Sham-controlThe sham-control in this trial is cystoscopy only. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has signed an informed consent form (ICF).
- Men ≥ 45 years.
- Symptomatic BPH with the following (all must be met):
- 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.
Key exclusion criteria (32 listed)
- Subjects who meet ANY of the following exclusion criteria will not participate in the trial:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urocross implantUrocross implant inserted via delivery catheter | Device | Urocross implant group |
| Sham-controlCystoscopy | Diagnostic test | Sham-control group |
Primary outcome
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 months post-procedure
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.
1 secondary outcome
Percent change in Total IPSS for subjects randomized to the Urocross Implant
Time frame: 3 months post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin T. McVary principal investigator
Loyola University
Daniel B. Rukstalis principal investigator
Carilion Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urocross implant in people with Benign Prostatic Hyperplasia, run by Prodeon Medical, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Urocross Expander Implant (time frame: more than 7 days post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.