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It was determined that the volume imaging was not working.
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Determine if volume imaging can diagnose bone, ligament, muscle injuries.
The investigators are attempting to determine if Volume imaging (a new type of ultrasound imaging)can accurately diagnose injuries of the muscle ligaments, tendons and bones when compared to conventional ultrasound imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volume Imaging scan | Experimental | New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Scan | Procedure | Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging | Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan. | Up to 13 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Jacobson, M.D. | University of Michigan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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Patients who are referred for an ultrasound of the extremity will be asked to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Volume Imaging Scan | New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9. Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries. Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients were randomly evaluated without pre-selection of gender or race
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| ID | Title | Description |
|---|---|---|
| BG000 | Volume Imaging Scan | New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9. Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries. Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging | Both ultrasound and volume imaging scans were done on the same day. For all scanned patients, the ultrasound technologist took a volume of images focusing where the patient had symptoms. The study PI reviewed the images, then went back in to do second scan. It took 5 to 10 minutes to complete a conventional ultrasound scan and up to 3 minutes to complete a volume imaging ultrasound scan. | Posted | Number | percent correlation | Up to 13 minutes |
|
up to 1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Volume Imaging Scan | New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9. Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries. Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician. |
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16 patients were studied as part of a pilot project to determine if 3D ultrasound offers any benefit over routine standard ultrasound imaging of the extremity. The study was terminated after evaluating 16 subjects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon Jacobson, MD | University of Michigan | 734-936-4365 | jjacobsn@umich.edu |
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| ID | Term |
|---|---|
| D013708 | Tendon Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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|
| Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). | Device | The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to x-ray the muscle and tendon injuries. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
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| D055585 |
| Physical Phenomena |