18 and older, any sex, with Endovascular Procedures. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cohen's Kappa Coefficient (κ)Primary· Up to 8 hours post procedure
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.
Group
Value
95% CI
Saranas Early Bird Bleed Monitoring System (EBBMS)
0.84
Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized TomographySecondary· Up to 8 hours post procedure
Sensitivity measures the proportion of positives bleed detection events that are correctly identified by the EBBMS as compared to post-procedural computerized tomography.
Group
Value
95% CI
Saranas Early Bird Bleed Monitoring System (EBBMS)
60
Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized TomographySecondary· Up to 8 hours post procedure
Specificity relates to the EBBMS' ability to correctly reject non-bleeding events as compared to post-procedural computerized tomography.
Group
Value
95% CI
Saranas Early Bird Bleed Monitoring System (EBBMS)
75
Adverse events — posted to ClinicalTrials.gov
Time frame: 5 months.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Saranas Early Bird Bleed Monitoring System (EBBMS)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Saranas, Inc.
Last refreshed: 28 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03621202.