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NCT05530798 · ClinicalTrials.gov registry record · NA
CEUS For Intraoperative Spinal Cord Injury
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT05530798: Completed NA study, sponsored by Medical University of South Carolina.
NCT05530798 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05530798, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies. Currently, intraoperative neuromonitoring (IONM) remains the gold standard for predicting and preventing post-operative deficits from these procedures. However, there is a paucity in the field of spine surgery for further, non-invasive biomarkers that can help detect and prognosticate the degree of spinal cord injury intraoperatively. Contrast enhanced ultrasound (CEUS) is a radiation free imaging modality that utilizes nanobubble technology to allow for visualization of the macro- and microvascular architecture of soft tissue structures. Despite being currently approved for the use in hepatology and cardiology, it has remained absent from the field of spinal cord injury. The study team aims to evaluate and quantify micro- and macrovascular changes that lead to areas of hyper-perfusion as well as areas of ischemia intraoperatively in patients that undergo elective cervicothoracic posterior decompression for chronic compression. In addition, the study team aims to assess the efficacy of CEUS in detecting microvascular changes that correlate with IONM changes and predicting degree and recovery of post-operative neurologic deficits from intraoperative spinal cord injury. The study team hypothesizes that following decompression, subjects will have detectable levels of microvascular changes causing areas of hypoperfusion and reperfusion injury. Second, the study team hypothesizes that these perfusion changes will correlate with intraoperative neuromonitoring changes and can predict and prognosticate the degree of post-operative neurologic injury.
Primary Outcome
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 p
Interventions
- DEVICE Definity Perflutren Lipid Microsphere Ultrasound Contrast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-12-01 |
| Est. Completion | 2025-08-01 |
| Phase | NA |
What the finished NCT05530798 record still lists
NCT05530798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Definity Perflutren Lipid Microsphere Ultrasound Contrast is the first listed.
NCT05530798 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05530798 about?
NCT05530798 is a clinical study titled "CEUS For Intraoperative Spinal Cord Injury". Spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies. Currently, intraoperative neuromonitoring (IONM) remains the gold standard for predicting and preventing post-operative d...
What is the current status of trial NCT05530798?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2023-12-01. Estimated completion is 2025-08-01.
What interventions are being tested in trial NCT05530798?
The interventions under investigation include: Definity Perflutren Lipid Microsphere Ultrasound Contrast (DEVICE).
Who is sponsoring clinical trial NCT05530798?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05530798's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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