To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
66
Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
North Florida Regional Medical Center
Gainesville, Florida, United States
Morristown Medical Center
Morristown, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Houston Methodist Hospital
Houston, Texas, United States
Cohen's Kappa Coefficient (κ)
Statistic measures concordance in detecting bleeds between the Saranas EBBMS and post-procedural CT. Cohen suggested the Kappa result be interpreted as follows: values ≤ 0 as indicating no agreement and 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41- 0.60 as moderate, 0.61-0.80 as substantial, and 0.81-1.00 as almost perfect agreement.
Time frame: Up to 8 hours post procedure
Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
Sensitivity measures the proportion of positives bleed detection events that are correctly identified by the EBBMS as compared to post-procedural computerized tomography.
Time frame: Up to 8 hours post procedure
Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
Specificity relates to the EBBMS' ability to correctly reject non-bleeding events as compared to post-procedural computerized tomography.
Time frame: Up to 8 hours post procedure
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Texas Heart Institute
Houston, Texas, United States