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Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcatheter Arterial Micro-Embolization
Sponsored by
Next Biomedical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

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

Inclusion Criteria: Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months VAS score exceeding 50mm An adult male and female over 50 years of age Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks A person who agrees to allow existing drug treatment during the clinical trial, but not to be subject to additional drug administration or new conservative treatment for symptom control Exclusion Criteria: A locally infected patient A person whose life expectancy is less than six months A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain) A person diagnosed with rheumatism or infectious arthritis Who had previous knee surgery INR 2.5 or less than 30,000 platelets Anaphylaxis-causing iodine allergy Patients with renal dysfunction or impaired renal function who have been diagnosed with less than 45 GFR (eGFR) within the last 60 days Those who have a taboo on MR videos Pregnant women Other cases where it is deemed inappropriate to participate in this clinical trial at the discretion of the researcher

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Transcatheter Arterial Micro-Embolization

    Arm Description

    If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.

    Outcomes

    Primary Outcome Measures

    Rate of WOMAC Score Reduction
    The rate of change of WOMAC Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
    Rate of VAS Score (patient pain intensity) Reduction
    The rate of change of VAS Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.

    Secondary Outcome Measures

    Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
    The rate of change of WORMS before and after application of medical devices for clinical trials. MRI images of cartilage, marrow abnormality, bone cysts, bone attrition, ostephytes, menisci, ligaments, and synovitis are scored and recorded.
    The rate of reduction of medication
    The rate of change of medication before and after application of medical devices for clinical trials.
    The rate of discontinuation of combination treatment
    The rate of change of combination treatment before and after application of medical devices for clinical trials.

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    June 20, 2023
    Sponsor
    Next Biomedical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05917028
    Brief Title
    Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis
    Official Title
    A Single Arm, Single Center, Open Label , Pilot Clinical Study to Evaluate the Efficacy and Safety of Transcatheter Arterial Micro Embolization (TAME) Using Nexsphere F in Patients With Knee Degenerative Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Next Biomedical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Among knee degenerative osteoarthritis patients aged 50 or older, it will prove the therapeutic effect and safety of Nexsphere-F embolization for patients who need additional treatment because pain is not controlled even if conventional treatments are taken.
    Detailed Description
    This clinical trial is a single arm, single center, open label, and pilot clinical trial to prove the performance and safety of Nexsphere-F in patients over the age of 50 who need additional treatment because pain is not controlled even after conventional treatments are taken. Since consent cannot be obtained during surgery from a subject who meets the inclusion and exclusion criteria, a written consent is obtained in advance between four weeks before the procedure and the day. As one of the usual orthopedic evaluations, baseline MRI will be performed and WORMS will be evaluated. In addition, the WOMAC score and the VAS score will be measured before the procedure and used as a baseline for evaluation variables. Since it is a pilot study to evaluate the validity, all subjects will undergo a Transcatheter Arterial Micro-Embolization (TAME).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Transcatheter Arterial Micro-Embolization
    Arm Type
    Experimental
    Arm Description
    If abnormal blood vessels related to pain are identified by angiography, selective embolization is performed using Nexsphere-F.
    Intervention Type
    Device
    Intervention Name(s)
    Transcatheter Arterial Micro-Embolization
    Intervention Description
    Participants will undergo TAME with Nexsphere-F.
    Primary Outcome Measure Information:
    Title
    Rate of WOMAC Score Reduction
    Description
    The rate of change of WOMAC Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
    Time Frame
    1 day, 14 days, 1 month, 3 months, 6 months
    Title
    Rate of VAS Score (patient pain intensity) Reduction
    Description
    The rate of change of VAS Score before and after application of medical devices for clinical trials. The definition of clinical success is a reduction of more than 50% of baseline scores (WOMAC and VAS) in six-month observations after at least one knee vascular embolization without additional combination treatment.
    Time Frame
    1 day, 14 days, 1 month, 3 months, 6 months
    Secondary Outcome Measure Information:
    Title
    Rate of change in WORMS (Whole-Organ Magnetic Resonance Imaging Score)
    Description
    The rate of change of WORMS before and after application of medical devices for clinical trials. MRI images of cartilage, marrow abnormality, bone cysts, bone attrition, ostephytes, menisci, ligaments, and synovitis are scored and recorded.
    Time Frame
    1 month
    Title
    The rate of reduction of medication
    Description
    The rate of change of medication before and after application of medical devices for clinical trials.
    Time Frame
    6 months
    Title
    The rate of discontinuation of combination treatment
    Description
    The rate of change of combination treatment before and after application of medical devices for clinical trials.
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Number of participants with abnormal cases during follow-up (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)
    Description
    Abnormal cases that occurred after the application of medical devices for clinical trials (AVN, skin necrosis, dermal toxicity, acute lower extremity ischemia)
    Time Frame
    1 day, 14 days, 1 month, 3 months, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Those who fall under Kellgren-Lawrence grade 2 to 3 according to the criteria in accordance with ACR guidelines and X-ray findings used within 12 months VAS score exceeding 50mm An adult male and female over 50 years of age Preservative therapy Glucosamine chondroitin sulfate/physiological therapy and rehabilitation exercises, and joint injections of hyaluronic acid for more than 12 weeks A person who agrees to allow existing drug treatment during the clinical trial, but not to be subject to additional drug administration or new conservative treatment for symptom control Exclusion Criteria: A locally infected patient A person whose life expectancy is less than six months A person with symptoms of lower extremities that are considered secondary to atherosclerosis or arterial vascular disease (ex: claudication ischemic rest pain) A person diagnosed with rheumatism or infectious arthritis Who had previous knee surgery INR 2.5 or less than 30,000 platelets Anaphylaxis-causing iodine allergy Patients with renal dysfunction or impaired renal function who have been diagnosed with less than 45 GFR (eGFR) within the last 60 days Those who have a taboo on MR videos Pregnant women Other cases where it is deemed inappropriate to participate in this clinical trial at the discretion of the researcher
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Min Jung
    Phone
    +82-32-454-4800
    Email
    next@nextbiomedical.co.kr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sungmo Moon
    Phone
    +82-32-454-4800
    Email
    next@nextbiomedical.co.kr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Min Jung
    Organizational Affiliation
    Severance Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Transcatheter Arterial Micro-Embolization (TAME) Using Nexsphere-F in Patients With Knee Degenerative Osteoarthritis

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