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

Primary Purpose

Endovascular Procedures

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Saranas Early Bird Bleed Monitoring System (EBBMS)
Sponsored by
Saranas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endovascular Procedures focused on measuring large bore, femoral access, internal bleeding, retroperitoneal hematoma, bleeding complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • North Florida Regional Medical Center
  • Morristown Medical Center
  • Columbia University Medical Center
  • Houston Methodist Hospital
  • Texas Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Saranas Early Bird Bleed Monitoring System (EBBMS)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 30, 2018
Last Updated
December 24, 2020
Sponsor
Saranas, Inc.
Collaborators
Proxima Clinical Research, Medical Metrics Diagnostics, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT03621202
Brief Title
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saranas, Inc.
Collaborators
Proxima Clinical Research, Medical Metrics Diagnostics, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endovascular Procedures
Keywords
large bore, femoral access, internal bleeding, retroperitoneal hematoma, bleeding complications

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saranas Early Bird Bleed Monitoring System (EBBMS)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Saranas Early Bird Bleed Monitoring System (EBBMS)
Intervention Description
Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
Primary Outcome Measure Information:
Title
Cohen's Kappa Coefficient (κ)
Description
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
Secondary Outcome Measure Information:
Title
Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
Description
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
Title
Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Genereux, M.D.
Organizational Affiliation
Gagnon Cardiovascular Institute, Morristown Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida Regional Medical Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Heart Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events

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