Evaluation of a Novel Method of Contrast Volume Quantification - AVERT PLUS 2.0
NCT ID: NCT02578173
Last Updated: 2016-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
20 participants
OBSERVATIONAL
2015-10-31
2016-03-31
Brief Summary
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Detailed Description
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The AVERT PLUS is an FDA 510K cleared device which consists of 1) a contrast delivery modulator designed to reduce unnecessary contract dye delivery to the patient during angiography (coronary or peripheral) and 2) a concomitant contrast monitoring 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 contrast volume used during clinically indicated angiography in the cardiac catheterization laboratory.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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AVERT PLUS
The AVERT PLUS will be used on the first 10 patients enrolled in the study. The AVERT PLUS is a contrast monitoring system which is used to precisely measure the volume of contrast delivered to the patient.
AVERT PLUS
Non device group
The second group of 10 patients will undergo the scheduled angiography using the standard method of measuring contrast dye delivery.
No interventions assigned to this group
Interventions
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AVERT PLUS
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Anand Prasad
OTHER
Responsible Party
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Anand Prasad
Assistant Professor of Medicine
Principal Investigators
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Michele Shepard
Role: STUDY_DIRECTOR
Osprey Medical, Inc
Other Identifiers
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HSC20150682H
Identifier Type: -
Identifier Source: org_study_id
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