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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Active

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

XFLO Expander System

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

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.

Sites / Locations

Australian Clinical Trials Pty Ltd
University Health Network
Brunswick Medical Center
National Center of Urology
China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm-1: Device implantation for 1 month

Arm-2: Device implantation for 6 months

Arm-3: Device implantation for 12 months

Arm Description

Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.

Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.

Outcomes

Primary Outcome Measures

Freedom from Unanticipated adverse device effects (UADEs)

Measure any device or procedure related adverse events

Freedom from Unanticipated adverse device effects (UADEs)

Measure any device or procedure related adverse events

Secondary Outcome Measures

Freedom from Unanticipated adverse device effects (UADEs)

Measure any device or procedure related adverse events

Freedom from Unanticipated adverse device effects (UADEs)

Measure any device or procedure related adverse events

Change in International Prostate Symptom Score (IPSS)

Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)

Change in International Prostate Symptom Score (IPSS)

Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)

Full Information

NCT ID

NCT03758222

First Posted

November 26, 2018

Last Updated

July 25, 2022

Sponsor

MedeonBio, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03758222

Brief Title

Safety and Feasibility of the XFLO Expander System (Mercury)

Acronym

EXPANDER-1

Official Title

A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 7, 2018 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedeonBio, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm-1: Device implantation for 1 month

Arm Type

Experimental

Arm Description

Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

Arm Title

Arm-2: Device implantation for 6 months

Arm Type

Experimental

Arm Description

Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.

Arm Title

Arm-3: Device implantation for 12 months

Arm Type

Experimental

Arm Description

Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.

Intervention Type

Device

Intervention Name(s)

XFLO Expander System

Other Intervention Name(s)

Mercury

Intervention Description

Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)

Primary Outcome Measure Information:

Title

Freedom from Unanticipated adverse device effects (UADEs)

Description

Measure any device or procedure related adverse events

Time Frame

1 month (Arm-1)

Title

Freedom from Unanticipated adverse device effects (UADEs)

Description

Measure any device or procedure related adverse events

Time Frame

6 months (Arm-2)

Secondary Outcome Measure Information:

Title

Freedom from Unanticipated adverse device effects (UADEs)

Description

Measure any device or procedure related adverse events

Time Frame

7 months (Arm-1)

Title

Freedom from Unanticipated adverse device effects (UADEs)

Description

Measure any device or procedure related adverse events

Time Frame

12 months (Arm-2)

Title

Change in International Prostate Symptom Score (IPSS)

Description

Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)

Time Frame

1 month and 7 months (Arm-1)

Title

Change in International Prostate Symptom Score (IPSS)

Description

Measure improvement in lower urinary tract symptoms related to benign prostatic hyperplasia (BPH)

Time Frame

6 and 12 months (Arm-2)

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Benign prostatic hyperplasia (BPH) is a male disease

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry Woo, MD

Organizational Affiliation

Australian Clinical Trials Pty Ltd

Official's Role

Principal Investigator

Facility Information:

Facility Name

Australian Clinical Trials Pty Ltd

City

Wahroonga

State/Province

New South Wales

ZIP/Postal Code

2076

Country

Australia

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Brunswick Medical Center

City

Montréal

Country

Canada

Facility Name

National Center of Urology

City

Tbilisi

ZIP/Postal Code

0144

Country

Georgia

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

Safety and Feasibility of the XFLO Expander System (Mercury)

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