Benign Prostatic HyperplasiaEXPANDER-1NCT03758222
Safety and Feasibility of the XFLO Expander System (Mercury)
A study testing XFLO Expander System in people with Benign Prostatic Hyperplasia, run by MedeonBio, Inc. at 5 sites in 4 countries.
Trial summary
To demonstrate the safety and feasibility of the Mercury Expander system and procedure to treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- XFLO Expander System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 7 Nov 2018to Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male gender
- Age ≥ 50 years
- Prostate volume 30 - 80 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound (TRUS)
- Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound).
- Medication history
- Not on BPH related medication for the past 6 months.
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- If on BPH related medication:
- On 5-alpha-reductase inhibitors (ARIs), the patient must be on the medication for at least 3 months with a stable voiding pattern
- On alpha-blockers, the patient must be on the medication for at least 3 weeks with a stable voiding pattern
- Patients with symptomatic BPH and related lower urinary tract symptoms (LUTS):
- With International Prostate Symptom Score (IPSS) > 13; Qmax < 12 mL/sec on a voided volume ≥125 mL; Post-void residual (PVR) < 250 mL; QoL score ≥ 3
Who cannot join
- Previous BPH procedure
- Median prostatic lobe or high bladder neck
- Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- Elevated Prostate Specific Antigen (PSA) ≥ 10 ng/mL unless negative biopsy within last 6 months, or a positive biopsy showing cancer
- Cystolithiasis within the prior 3 months
- History of neurogenic bladder or urinary retention with PVR >1000mL.
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- Serum creatinine >1.8 mg/dl or upper-tract disease which compromises renal function
- Current or recent Urinary Tract Infection (UTI) or disease
- Known allergy to nickel
- Life expectancy of less than 24 months
- Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin ≤ 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
- Anticipated need for additional surgery or treatments for comorbidities during the study period.
- Current gross hematuria
- Other co-morbidities that could impact the study results
- Unable or unwilling to complete all required questionnaires and follow-up assessments
- Unable or unwilling to sign informed consent form
- Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Canada2 sites
Brunswick Medical Center
Montreal
University Health Network
Toronto, Ontario
Australia1 site
Australian Clinical Trials Pty Ltd
Wahroonga, New South Wales, 2076
About this study
Official title: A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)
To demonstrate the safety and feasibility of the Mercury Expander system and procedure to treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia.
Read the detailed description
A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the Mercury Expander system in patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia (BPH).
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- XFLO Expander System
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XFLO Expander SystemDevice
Also called Mercury
Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)
| Study group | Role | What they receive |
|---|---|---|
| Arm-1: Device implantation for 1 month | Experimental | Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved. Receives: Device: XFLO Expander System |
| Arm-2: Device implantation for 6 months | Experimental | Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved. Receives: Device: XFLO Expander System |
| Arm-3: Device implantation for 12 months | Experimental | Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved. Receives: Device: XFLO Expander System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Unanticipated adverse device effects (UADEs)
Measure any device or procedure related adverse events
Measured: 1 month (Arm-1)
Freedom from Unanticipated adverse device effects (UADEs)
Measure any device or procedure related adverse events
Measured: 6 months (Arm-2)
Secondary outcomes (4)
Freedom from Unanticipated adverse device effects (UADEs)
Measure any device or procedure related adverse events
Measured: 7 months (Arm-1)
Freedom from Unanticipated adverse device effects (UADEs)
Measure any device or procedure related adverse events
Measured: 12 months (Arm-2)
Change in International Prostate Symptom Score (IPSS)
Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)
Measured: 1 month and 7 months (Arm-1)
Change in International Prostate Symptom Score (IPSS)
Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)
Measured: 6 and 12 months (Arm-2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start7 Nov 2018
- Primary completionDec 2022 (estimated)
- Study completionAug 2025 (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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedeonBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henry Woo, MD, Principal investigator, Australian Clinical Trials Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758222
- Sponsor's protocol ID
- 10-CIP-1164
- Other IDs
- PN-7585,-7998 10-MSC-1082
- Acronym
- EXPANDER-1
- Status last verified
- Jul 2022
- First submitted
- 26 Nov 2018
- Last updated
- 26 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)
- ClinicalTrials.gov ID
- NCT03758222
- Acronym / sponsor ID
- EXPANDER-1 / 10-CIP-1164
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (actual)
- Lead sponsor
- MedeonBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Nov 2018 (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 feasibility of the Mercury Expander system and procedure to treat patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia.
Detailed description
A prospective, non-randomized, two-arm, multi-center clinical trial designed to evaluate the safety and feasibility of the Mercury Expander system in patients with lower urinary tract symptoms (LUTS) secondary to urinary outflow obstruction from benign prostatic hyperplasia (BPH).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm-1: Device implantation for 1 month | Experimental | Device: XFLO Expander SystemTreatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved. |
| Arm-2: Device implantation for 6 months | Experimental | Device: XFLO Expander SystemTreatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved. |
| Arm-3: Device implantation for 12 months | Experimental | Device: XFLO Expander SystemTreatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male gender
- Age ≥ 50 years
- Prostate volume 30 - 80 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound (TRUS)
- Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound).
- Medication history
Key exclusion criteria (17 listed)
- Previous BPH procedure
- Median prostatic lobe or high bladder neck
- Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
- Elevated Prostate Specific Antigen (PSA) ≥ 10 ng/mL unless negative biopsy within last 6 months, or a positive biopsy showing cancer
- Cystolithiasis within the prior 3 months
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 |
|---|---|---|
| XFLO Expander SystemAlso: MercuryImplantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH) | Device | Arm-1: Device implantation for 1 month, Arm-2: Device implantation for 6 months, Arm-3: Device implantation for 12 months |
Primary outcome
Freedom from Unanticipated adverse device effects (UADEs)
Time frame: 1 month (Arm-1)
Measure any device or procedure related adverse events
Freedom from Unanticipated adverse device effects (UADEs)
Time frame: 6 months (Arm-2)
Measure any device or procedure related adverse events
4 secondary outcomes
Freedom from Unanticipated adverse device effects (UADEs)
Time frame: 7 months (Arm-1)
Freedom from Unanticipated adverse device effects (UADEs)
Time frame: 12 months (Arm-2)
Change in International Prostate Symptom Score (IPSS)
Time frame: 1 month and 7 months (Arm-1)
Change in International Prostate Symptom Score (IPSS)
Time frame: 6 and 12 months (Arm-2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
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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.
Henry Woo, MD principal investigator
Australian Clinical Trials Pty Ltd
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XFLO Expander System in people with Benign Prostatic Hyperplasia, run by MedeonBio, Inc. at 5 sites in 4 countries.
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 11 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, Australia, Georgia, Taiwan. 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. 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?
Results are not available in the source record.
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?
Freedom from Unanticipated adverse device effects (UADEs) (time frame: 1 month (Arm-1)). 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 26 Jul 2022.