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OpenTrials
Completed

NCT Number: NCT03621202

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

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.

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Key information

Conditions

Endovascular Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Florida Regional Medical Center, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age
  • Willing and capable to sign an Informed Consent form
  • Planned endovascular procedure such as trans-femoral transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty, percutaneous coronary intervention, complex or high-risk percutaneous coronary intervention requiring hemodynamic support device (Impella 2.5, Impella CP, and ECMO), endovascular aortic repair (EVAR), any other endovascular procedures requiring arterial or venous access or surgical insertion of hemodynamic support

Exclusion criteria

  • Subject is participating, or planning to participate in a clinical trial or study of an investigational product that may influence the data collected for this investigation
  • Inability to access artery or vein for the endovascular procedure
  • Current active bleeding
  • Pre-procedural conditions precluding the realization of a post-procedural CT scan
  • Pregnancy
  • Mental disability or any other lack of fitness, in the Investigator's opinion, to preclude subject's participation in or ability to complete the study as planned

Treatment and study plan

Saranas Early Bird Bleed Monitoring System (EBBMS)

Device

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

Primary outcomes

  1. Cohen's Kappa Coefficient (κ)

    Time frame: 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.

Secondary outcomes

  1. Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography

    Time frame: 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.

  2. Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Saranas, Inc.

Industry

Collaborators

  • Medical Metrics Diagnostics, Inc
  • Proxima CRO

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2018
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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