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Assessing the Comparability of 2D and 4D Ultrasound Measurements

Primary Purpose

Carpal Tunnel

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
4D Ultrasound
2D ultrasound
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Carpal Tunnel

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Healthy Volunteers

Exclusion Criteria:

  • Cervical radiculopathy
  • Rheumatoid arthritis
  • Osteoarthritis
  • Flexor tendinitis
  • Gout
  • Hemodialysis
  • Sarcoidosis
  • Peripheral nerve disease
  • Amyloidosis
  • Traumatic injury - same arm

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    4D Ultrasound

    2D ultrasound

    Arm Description

    4D ultrasound imaging of the carpal tunnel. 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury. The same patients will be imaged with both 2D and 4D transducers.

    2D ultrasound imaging of the carpal tunnel. 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury.The same patients will be imaged with both 2D and 4D transducers.

    Outcomes

    Primary Outcome Measures

    shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3)
    the relative motion of the SSCT and FDS3 on longitudinal video clips, expressed as a ratio of SSCT/FDS3

    Secondary Outcome Measures

    motion of the median nerve
    on cross sectional images, in mm from starting point, while the wrist is flexed
    shape of median nerve
    on cross sectional images, both cross sectional area in mm squared, and shape in terms of circularity (X axis divided by Y axis)

    Full Information

    First Posted
    January 15, 2016
    Last Updated
    August 4, 2017
    Sponsor
    Mayo Clinic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02666911
    Brief Title
    Assessing the Comparability of 2D and 4D Ultrasound Measurements
    Official Title
    Assessing the Comparability of 2D and 4D Ultrasound Measurements of Human Carpal Tunnel Synovium, Median Nerve and Tendon Displacement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Equipment to run the study was not available
    Study Start Date
    January 2018 (Anticipated)
    Primary Completion Date
    January 2019 (Anticipated)
    Study Completion Date
    January 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mayo Clinic

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Investigators will recruit 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury. Images will be captured twice, first with the 2D transducer and then with the 4D transducer and compared to images captured with the new 4D transducer, using the same movement data analysis protocols. Investigators will also assess the inter and intrarater reliability of the 4D transducer images, by using two different sonographers, both trained in the technique, measuring the same blinded images on separate occasions, at least two weeks apart. The overall goal of this project is to assess the reliability, or reproducibility, of measurements in normal subjects using a novel 4D ultrasonographic method to characterize the subsynovial connective tissue (SSCT) and detect motion between SSCT, median nerve and tendon motion for the evaluation and diagnosis of patients with disorders affecting the carpal tunnel, especially carpal tunnel syndrome (CTS).
    Detailed Description
    CTS can be diagnosed in many ways, but there are currently no non-invasive methods to assess the physiology within the carpal tunnel, which may help select treatment and predict treatment outcomes. The investigators have shown in preliminary work that differences in the motion of various structures within the carpal tunnel, including the median nerve, flexor tendons, and SSCT, vary in normal subjects and those with CTS. A clinical trial is already under way to assess conventional ultrasound imaging to predict outcomes of CTS treatments. In this study investigators wish to compare the current ultrasound methods, which involve moving two dimensional images, with a new technology which captures moving images in three dimensions (i.e., four dimensions, or 4D). If successful, a single 4D measurement could replace longitudinal and transverse 2D images, saving time and allowing better understanding of the relationship between displacements in both planes.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    4D Ultrasound
    Arm Type
    Experimental
    Arm Description
    4D ultrasound imaging of the carpal tunnel. 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury. The same patients will be imaged with both 2D and 4D transducers.
    Arm Title
    2D ultrasound
    Arm Type
    Active Comparator
    Arm Description
    2D ultrasound imaging of the carpal tunnel. 20 healthy volunteers between the ages of 18 and 80, who have no history of carpal tunnel syndrome or wrist injury.The same patients will be imaged with both 2D and 4D transducers.
    Intervention Type
    Procedure
    Intervention Name(s)
    4D Ultrasound
    Intervention Description
    Each subject will be imaged lying supine on imaging table with affected arm outstretched on Plexiglass board. An ultrasound scanner equipped with 15L8 linear array transducer will be set to depth of 20-25 mm with a 15MHz image acquisition frequency (for longitudinal and transverse imaging) and the same ultrasound machine equipped with 4D transducer will be used. Ultrasound evaluation will be performed by a sonographer trained in the pertinent image acquisition procedures. The image acquisition frame rate will be maintained at 70Hz, and the image compression will be set to low.
    Intervention Type
    Procedure
    Intervention Name(s)
    2D ultrasound
    Intervention Description
    Each subject will be imaged lying supine on imaging table with affected arm outstretched on Plexiglass board. An ultrasound scanner equipped with 15L8 linear array transducer will be set to depth of 20-25 mm with a 15MHz image acquisition frequency (for longitudinal and transverse imaging) and the same ultrasound machine equipped with 4D transducer will be used. Ultrasound evaluation will be performed by a sonographer trained in the pertinent image acquisition procedures. The image acquisition frame rate will be maintained at 70Hz, and the image compression will be set to low.
    Primary Outcome Measure Information:
    Title
    shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3)
    Description
    the relative motion of the SSCT and FDS3 on longitudinal video clips, expressed as a ratio of SSCT/FDS3
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    motion of the median nerve
    Description
    on cross sectional images, in mm from starting point, while the wrist is flexed
    Time Frame
    1 year
    Title
    shape of median nerve
    Description
    on cross sectional images, both cross sectional area in mm squared, and shape in terms of circularity (X axis divided by Y axis)
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Healthy Volunteers Exclusion Criteria: Cervical radiculopathy Rheumatoid arthritis Osteoarthritis Flexor tendinitis Gout Hemodialysis Sarcoidosis Peripheral nerve disease Amyloidosis Traumatic injury - same arm
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Peter C. Amadio, M.D.
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Assessing the Comparability of 2D and 4D Ultrasound Measurements

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