- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02666911
Assessing the Comparability of 2D and 4D Ultrasound Measurements
August 4, 2017 updated by: Peter C. Amadio, M.D., Mayo Clinic
Assessing the Comparability of 2D and 4D Ultrasound Measurements of Human Carpal Tunnel Synovium, Median Nerve and Tendon Displacement
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Healthy Volunteers
Exclusion Criteria:
- Cervical radiculopathy
- Rheumatoid arthritis
- Osteoarthritis
- Flexor tendinitis
- Gout
- Hemodialysis
- Sarcoidosis
- Peripheral nerve disease
- Amyloidosis
- Traumatic injury - same arm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 4D Ultrasound
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.
|
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.
|
Active Comparator: 2D ultrasound
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
shear index between SSCT and flexor digitorum superficialis 3 tendon (FDS3)
Time Frame: 1 year
|
the relative motion of the SSCT and FDS3 on longitudinal video clips, expressed as a ratio of SSCT/FDS3
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
motion of the median nerve
Time Frame: 1 year
|
on cross sectional images, in mm from starting point, while the wrist is flexed
|
1 year
|
shape of median nerve
Time Frame: 1 year
|
on cross sectional images, both cross sectional area in mm squared, and shape in terms of circularity (X axis divided by Y axis)
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter C. Amadio, M.D., Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2018
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
January 1, 2019
Study Registration Dates
First Submitted
January 15, 2016
First Submitted That Met QC Criteria
January 25, 2016
First Posted (Estimate)
January 28, 2016
Study Record Updates
Last Update Posted (Actual)
August 7, 2017
Last Update Submitted That Met QC Criteria
August 4, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-008487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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