Trial Outcomes & Findings for CEUS For Intraoperative Spinal Cord Injury (NCT NCT05530798)
NCT ID: NCT05530798
Last Updated: 2026-09-04
Results Overview
Contrast-enhanced ultrasound (CEUS) images were obtained intraoperatively before and after spinal cord decompression. Signal intensity (echogenicity) within the spinal cord at the decompressed segment was quantified from CEUS images and measured in dB/MHz/cm. The outcome measure was the change in signal intensity from pre-decompression imaging to post-decompression imaging. A positive value indicates increased perfusion signal following decompression, while a negative value indicates decreased perfusion signal.
COMPLETED
NA
20 participants
Intra-operative (approximately 3 hours)
2026-09-04
Participant Flow
No significant events occurred
Participant milestones
| Measure |
Contrast Enhanced Ultrasound Arm
Definity Perflutren Lipid Microsphere Ultrasound Contrast: 1) Before the spinal decompression surgery has started, the study team will inject the ultrasound contrast to visualize the spinal cord prior to decompression of the spinal cord.
2\) After the spinal cord has been decompressed, the study team will inject the ultrasound contrast to visualize the spinal cord directly after decompression of the spinal cord.
3\) Prior to completion and closure of the incision, the study team will once more inject the ultrasound contrast to visualize the spinal cord.
4\) A member of the research team will follow up with study participants within a week of the procedure by phone. The research staff will also review the participants' medical record for up to 360 days after your procedure to collect information on clinical outcomes and any additional treatments, tests or procedures the study participants may have had.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CEUS For Intraoperative Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Contrast Enhanced Ultrasound Arm
n=20 Participants
Definity Perflutren Lipid Microsphere Ultrasound Contrast: 1) Before the spinal decompression surgery has started, the study team will inject the ultrasound contrast to visualize the spinal cord prior to decompression of the spinal cord.
2\) After the spinal cord has been decompressed, the study team will inject the ultrasound contrast to visualize the spinal cord directly after decompression of the spinal cord.
3\) Prior to completion and closure of the incision, the study team will once more inject the ultrasound contrast to visualize the spinal cord.
4\) A member of the research team will follow up with study participants within a week of the procedure by phone. The research staff will also review the participants' medical record for up to 360 days after your procedure to collect information on clinical outcomes and any additional treatments, tests or procedures the study participants may have had.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=23 Participants
|
|
Age, Continuous
|
68.4 Years
STANDARD_DEVIATION 8.4 • n=23 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: Intra-operative (approximately 3 hours)Contrast-enhanced ultrasound (CEUS) images were obtained intraoperatively before and after spinal cord decompression. Signal intensity (echogenicity) within the spinal cord at the decompressed segment was quantified from CEUS images and measured in dB/MHz/cm. The outcome measure was the change in signal intensity from pre-decompression imaging to post-decompression imaging. A positive value indicates increased perfusion signal following decompression, while a negative value indicates decreased perfusion signal.
Outcome measures
| Measure |
Contrast Enhanced Ultrasound Arm
n=20 Participants
CEUS Arm
|
|---|---|
|
Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression
|
1.3 dB/MHz/cm
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Clinical Monitoring (12 months)To assess whether discreet areas of perfusion changes seen by Contrast Enhanced ultrasound in the spinal cord intraoperatively correlate with the neurologic and functional outcomes of subjects that undergo spinal cord decompression
Outcome measures
Outcome data not reported
Adverse Events
Contrast Enhanced Ultrasound Arm
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