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Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS (AVERT-PLUS)

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ClinicalTrials.gov Identifier: NCT02434055
Recruitment Status : Terminated (Business purposes)
First Posted : May 5, 2015
Last Update Posted : June 18, 2015
Sponsor:
Collaborator:
Osprey Medical, Inc
Information provided by (Responsible Party):
Anand Prasad, The University of Texas Health Science Center at San Antonio

Brief Summary:

Purpose: To evaluate the accuracy of the AVERT PLUS to monitor contrast volume used during angiographic procedures.

Research Design: The AVERT PLUS is an FDA 510K cleared device which consists of a contrast delivery modulator designed to reduce unnecessary contrast dye delivery to the patient during angiography (coronary or peripheral) and a concomitant system to precisely measure contrast volume delivered to the patient. This will be a first in man prospective observational study of the accuracy of this system to quantify contract volume used during clinically indicated angiography in the cardiac catheterization laboratory.


Condition or disease Intervention/treatment
Extravasation of Contrast Media Device: AVERT PLUS

Detailed Description:
Thirty consecutive subjects who consent to participate and are undergoing planned angiography will be enrolled. The AVERT PLUS is a system which is external to the patient and connected to the control syringe that the physician uses to deliver the contrast dye to the patient. For each injection that the physician performs, the starting syringe volume, the ending syringe volume, and the net contrast delivered to the patient will be recorded. At the same time, the net volume delivered to the patient will also be recorded from the AVERT PLUS console. For each injection, these two sets of variables will be compared to determine accuracy of the AVERT PLUS to quantify net contrast volume used.

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of a Novel Method of Contrast Volume Quantification - The AVERT PLUS
Study Start Date : April 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015



Primary Outcome Measures :
  1. Observational study of the accuracy of this system to quantify contrast volume during a clinical indicated procedure [ Time Frame: During procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with cardiovascular disease undergoing clinically indicated coronary or peripheral angiography
Criteria

Inclusion Criteria:

  • subjects aged 18 or older with cardiovascular disease scheduled to undergo clinically indicated coronary or peripheral angiography who give informed consent to participate.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434055


Sponsors and Collaborators
Anand Prasad
Osprey Medical, Inc
Investigators
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Study Director: Michele Shepard Osprey Medical, Inc
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Responsible Party: Anand Prasad, Assistant Professor of Medicine, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02434055    
Other Study ID Numbers: HSC20150190H
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Extravasation of Diagnostic and Therapeutic Materials
Pathologic Processes
Wounds and Injuries