At a glance
ClinicalIndex Comparison RecordN/ACompleted· 66 enrolled
Drug / intervention
Saranas Early Bird Bleed Monitoring System (EBBMS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study to Evaluate the Safety and Accuracy of the Saranas Early Bird Bleed Monitoring System for the Detection of Endovascular Procedure Related Bleeding Events
In Brief
A clinical study evaluating Saranas Early Bird Bleed Monitoring System (EBBMS) for Endovascular Procedures. Completed, enrolled 66 participants across 5 sites.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndovascular Procedures
CountriesUnited States
CollaboratorsProxima CRO, Medical Metrics Diagnostics, Inc
Timeline
N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 2018
Enrollment StartAug 2018
Primary CompletionJun 2019
TodayJul 2026
First PostedAug 8, 2018
Enrollment StartAug 13, 2018
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.9 years ago
Interventions
Saranas Early Bird Bleed Monitoring System (EBBMS)device
Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.