Trial Outcomes & Findings for Impact of Volume Imaging Using Diagnostic Ultrasound (NCT NCT01601782)
NCT ID: NCT01601782
Last Updated: 2018-01-19
Results Overview
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.
TERMINATED
NA
16 participants
Up to 13 minutes
2018-01-19
Participant Flow
Patients who are referred for an ultrasound of the extremity will be asked to participate in the study.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Volume Imaging Using Diagnostic Ultrasound
Baseline characteristics by cohort
| Measure |
Volume Imaging Scan
n=16 Participants
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.
|
|---|---|
|
Age, Continuous
|
25 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 13 minutesBoth 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.
Outcome measures
| Measure |
Volume Imaging Scan
n=16 Participants
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.
|
|---|---|
|
Accuracy of 3D Ultrasound Scanning Expressed as Percent Correlation Between Images From Conventional Ultrasound and Volume Imaging
|
NA percent correlation
Two sets of images were collected for all 16 participants. In each case the volume imaging was not sufficiently clear to allow for the diagnostic interpretation necessary to support any numerical correlation between the two scans.
|
Adverse Events
Volume Imaging Scan
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place