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Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events

NCT03621202 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-12-28

Study results available
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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.

Conditions

  • Endovascular Procedures

Interventions

DEVICE

Saranas Early Bird Bleed Monitoring System (EBBMS)

Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.

Sponsors & Collaborators

  • Proxima CRO

    collaborator INDUSTRY

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Saranas, Inc.

    lead INDUSTRY

Principal Investigators

  • Philippe Genereux, M.D. · Gagnon Cardiovascular Institute, Morristown Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-13
Primary Completion
2019-06-30
Completion
2019-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621202 on ClinicalTrials.gov