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ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

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ClinicalTrials.gov Identifier: NCT04065373
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
ivWatch, LLC

Study Description
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Brief Summary:
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch and fiber optic sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Condition or disease Intervention/treatment Phase
Infiltration of Peripheral IV Therapy Device: ivWatch Model 400 with SmartTouch and fiber optic sensor Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues
Actual Study Start Date : April 25, 2019
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : June 21, 2019

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MedlinePlus related topics: Dietary Fiber

Arms and Interventions
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Arm Intervention/treatment
Experimental: Non-Infiltrated Tissue
The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored a common peripheral IV site over a 24 hour observation period.
 Device: ivWatch Model 400 with SmartTouch and fiber optic sensor
The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored tissue at common IV sites over a 24 hour period.


Outcome Measures
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Primary Outcome Measures :
  1. Normal Tissue Red Notification Rate [ Time Frame: 24 Hours ]
    The ivWatch Model 400 issues red notifications to communicate the need for a clinician to check an IV site. A red notification suggests an increased likelihood that an IV infiltration may be occurring, with a greater likelihood relative to a yellow notification. This measure describes the average number of red notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the red notification rate was calculated using a negative binomial regression model.


Secondary Outcome Measures :
  1. Normal Tissue Yellow Notification Rate [ Time Frame: 24 Hours ]
    The ivWatch Model 400 issues yellow notifications to communicate the need for a clinician to check an IV site. A yellow notification suggests an increased likelihood that an IV infiltration may be occurring, although at a lower likelihood relative to a red notification. This measure describes the average number of yellow notifications issued by the ivWatch device in a given day when monitoring normal, non-infiltrated tissues. The 95% confidence interval for the yellow notification rate was calculated using a negative binomial regression model.

  2. Significant Skin Irritation or Disruption to Skin Integrity [ Time Frame: 24 Hours ]
    The number of IV sites with significant skin irritation or disruption to skin integrity assessed at the end of the study. The Clopper-Pearson method was used for estimating the binomial proportion confidence interval.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent
  • Pass health screen
  • 18 years or older

Exclusion Criteria:

  • Fail health screen
Contacts and Locations
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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): NCT04065373


Locations
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United States, Virginia
ivWatch, LLC
Williamsburg, Virginia, United States, 23185
Sponsors and Collaborators
ivWatch, LLC
Investigators
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Study Director: Marisa Cole Employee
More Information
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Responsible Party: ivWatch, LLC
ClinicalTrials.gov Identifier: NCT04065373    
Other Study ID Numbers: IVW-CLR-CS24-400
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No