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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 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 20 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05530798
The ClinicalTrials.gov registry entry for NCT05530798 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Definity Perflutren Lipid Microsphere Ultrasound Contrast is the first listed.
NCT05530798 reports 0 study locations.
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.
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