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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03758222




Registration number
NCT03758222
Ethics application status
Date submitted
26/11/2018
Date registered
29/11/2018
Date last updated
26/07/2022

Titles & IDs
Public title
Safety and Feasibility of the XFLO Expander System (Mercury)
Scientific title
A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)
Secondary ID [1] 0 0
PN-7585,-7998 10-MSC-1082
Secondary ID [2] 0 0
10-CIP-1164
Universal Trial Number (UTN)
Trial acronym
EXPANDER-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - XFLO Expander System

Experimental: Arm-1: Device implantation for 1 month - Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

Experimental: Arm-2: Device implantation for 6 months - Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.

Experimental: Arm-3: Device implantation for 12 months - Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.


Treatment: Devices: XFLO Expander System
Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from Unanticipated adverse device effects (UADEs)
Timepoint [1] 0 0
1 month (Arm-1)
Primary outcome [2] 0 0
Freedom from Unanticipated adverse device effects (UADEs)
Timepoint [2] 0 0
6 months (Arm-2)
Secondary outcome [1] 0 0
Freedom from Unanticipated adverse device effects (UADEs)
Timepoint [1] 0 0
7 months (Arm-1)
Secondary outcome [2] 0 0
Freedom from Unanticipated adverse device effects (UADEs)
Timepoint [2] 0 0
12 months (Arm-2)
Secondary outcome [3] 0 0
Change in International Prostate Symptom Score (IPSS)
Timepoint [3] 0 0
1 month and 7 months (Arm-1)
Secondary outcome [4] 0 0
Change in International Prostate Symptom Score (IPSS)
Timepoint [4] 0 0
6 and 12 months (Arm-2)

Eligibility
Key inclusion criteria
* 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.
* 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
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* 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.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Australian Clinical Trials Pty Ltd - Wahroonga
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Montréal
Country [3] 0 0
Georgia
State/province [3] 0 0
Tbilisi
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedeonBio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03758222
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Woo, MD
Address 0 0
Australian Clinical Trials Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03758222