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Safety and Feasibility of the Mercury Expander System (EXPANDER-1)

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: NCT03758222
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
MedeonBio, Inc.

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Device: Mercury Expander System Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-In-Human Study to Evaluate the Safety and Feasibility of the Mercury Expander System
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm-1: Device implantation for 1 month
Treatment group receives intervention with the Mercury Expander System implantation for 1 month, and then retrieved.
Device: Mercury Expander System
Implantation and retrieval of the Mercury Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)

Experimental: Arm-2: Device implantation for 6 months
Treatment group receives intervention with the Mercury Expander System implantation for 6 months, and then retrieved.
Device: Mercury Expander System
Implantation and retrieval of the Mercury Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)




Primary Outcome Measures :
  1. Freedom from Unanticipated adverse device effects (UADEs) [ Time Frame: 1 month (Arm-1) ]
    Measure any device or procedure related adverse events

  2. Freedom from Unanticipated adverse device effects (UADEs) [ Time Frame: 6 months (Arm-2) ]
    Measure any device or procedure related adverse events


Secondary Outcome Measures :
  1. Freedom from Unanticipated adverse device effects (UADEs) [ Time Frame: 7 months (Arm-1) ]
    Measure any device or procedure related adverse events

  2. Freedom from Unanticipated adverse device effects (UADEs) [ Time Frame: 12 months (Arm-2) ]
    Measure any device or procedure related adverse events

  3. Change in International Prostate Symptom Score (IPSS) [ Time Frame: 1 month and 7 months (Arm-1) ]
    Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)

  4. Change in International Prostate Symptom Score (IPSS) [ Time Frame: 6 and 12 months (Arm-2) ]
    Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)



Information from the National Library of Medicine

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.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Benign prostatic hyperplasia (BPH) is a male disease
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male gender
  • Age ≥ 50 years
  • Prostate volume 25 - 80 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound (TRUS)
  • Prostatic urethra length of 3.5-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 4.0-8.0 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
    • Need temporary relief for ≥ 1 month

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.

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): NCT03758222


Contacts
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Contact: K. T. Venkateswara Rao, PhD 650-397-5100 kt@medeonbio.com

Locations
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Australia, New South Wales
Australian Clinical Trials Pty Ltd Recruiting
Wahroonga, New South Wales, Australia, 2076
Contact: Henry Woo, MD         
Principal Investigator: Henry Woo, MD         
Georgia
National Center of Urology Completed
Tbilisi, Georgia, 0144
Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Chi-Ping Huang, MD         
Sponsors and Collaborators
MedeonBio, Inc.
Investigators
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Principal Investigator: Henry Woo, MD Australian Clinical Trials Pty Ltd
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Responsible Party: MedeonBio, Inc.
ClinicalTrials.gov Identifier: NCT03758222    
Other Study ID Numbers: PN 07585
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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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
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Prostatic Diseases