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Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI
genicular ablation procedure
Sponsored by
TPM Medical Systems Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 18 years and older.
  • Diagnosed with primary degenerative osteoarthritis.
  • Complaining of knee pains
  • Patients clinically eligible for genicular nerve ablation procedure non-electively based on physical examination
  • Patient signed ICF

Exclusion Criteria:

  • Co-morbidities: patient suffers from neuropathy, bony tumors, traumatic fractures and DM.
  • Claustrophobic or failing cooperativity assessment of laying still during long MRI scans
  • Pregnancy or pregnancy suspicion
  • Enrolled in concurrent studies that may confound the results of this study
  • Clinical condition that in the investigator's opinion would not allow the subject to complete the study, e.g., tremor, extreme obesity, mental disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MRI scanning and the genicular ablation

    Arm Description

    patients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour

    Outcomes

    Primary Outcome Measures

    Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist

    Secondary Outcome Measures

    Full Information

    First Posted
    July 24, 2016
    Last Updated
    August 18, 2016
    Sponsor
    TPM Medical Systems Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02873611
    Brief Title
    Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression
    Official Title
    Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    TPM Medical Systems Ltd.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    MRI scanning and the genicular ablation
    Arm Type
    Experimental
    Arm Description
    patients undergoing both MRI scanning and the genicular ablation procedure. additional MRI testing of apprx. 0.5-1 hour
    Intervention Type
    Device
    Intervention Name(s)
    MRI
    Intervention Description
    patients will undergo an additional MRI testing of apprx. 0.5-1 hour.
    Intervention Type
    Procedure
    Intervention Name(s)
    genicular ablation procedure
    Primary Outcome Measure Information:
    Title
    Location and orientation of the relevant genicular nerves based on eye-balling inspection of MRI images by a radiologist
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18 years and older. Diagnosed with primary degenerative osteoarthritis. Complaining of knee pains Patients clinically eligible for genicular nerve ablation procedure non-electively based on physical examination Patient signed ICF Exclusion Criteria: Co-morbidities: patient suffers from neuropathy, bony tumors, traumatic fractures and DM. Claustrophobic or failing cooperativity assessment of laying still during long MRI scans Pregnancy or pregnancy suspicion Enrolled in concurrent studies that may confound the results of this study Clinical condition that in the investigator's opinion would not allow the subject to complete the study, e.g., tremor, extreme obesity, mental disorders.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yehuda Fridman, MD
    Phone
    972-3-7645262
    Email
    yehudaf@assuta.co.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yehuda Fridman, MD
    Organizational Affiliation
    Assuta MC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression

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