ivWatch Sensor: Device Validation for Infiltrated Tissues
NCT ID: NCT04064229
Last Updated: 2022-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
99 participants
INTERVENTIONAL
2019-04-03
2019-04-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Infiltrated Tissue
The ivWatch Model 400 sensors monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.
ivWatch Model 400 with SmartTouch Sensor
The ivWatch Model 400 with SmartTouch Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
ivWatch Model 400 with Fiber Optic Sensor
The ivWatch Model 400 with Fiber Optic Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
Interventions
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ivWatch Model 400 with SmartTouch Sensor
The ivWatch Model 400 with SmartTouch Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
ivWatch Model 400 with Fiber Optic Sensor
The ivWatch Model 400 with Fiber Optic Sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
Eligibility Criteria
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Inclusion Criteria
* Pass health screen by clinician
* 18 years or older
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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ivWatch, LLC
INDUSTRY
Responsible Party
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Locations
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ivWatch, LLC
Williamsburg, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IVW-CLR-CS27-400
Identifier Type: -
Identifier Source: org_study_id
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