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ivWatch Sensor: Device Validation for Infiltrated Tissues

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064229
Recruitment Status : Completed
First Posted : August 21, 2019
Results First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
ivWatch, LLC

Study Description
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Brief Summary:
A single arm trial consisting of 98 adult volunteers to assess the safety and efficacy of ivWatch sensors when observing infiltrated tissues at common sites for peripheral IV therapy.

Condition or disease Intervention/treatment Phase
Infiltration of Peripheral IV Therapy Device: ivWatch Model 400 with SmartTouch Sensor Device: ivWatch Model 400 with Fiber Optic Sensor Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ivWatch Sensor: Device Validation for Infiltrated Tissues
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : April 9, 2019
Actual Study Completion Date : April 9, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.

Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Red Notification Sensitivity to Infiltrated Tissues [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]
    The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a red notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.


Secondary Outcome Measures :
  1. Yellow Notification Sensitivity to Infiltrated Tissues [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]
    The ratio of the number of infiltrated IV sites where the ivWatch Model 400 device issued a yellow notification to the total number of infiltrated IV sites in the study. All infiltrations were limited to 10 mL of isotonic saline solution.

  2. Infiltrated Volume When Red Notification Issued [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]
    The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device.

  3. Infiltrated Volume When Yellow Notification Issued [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]
    The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device.

  4. Significant Skin Irritation or Disruption to Skin Integrity [ Time Frame: After each participant has been infiltrated, an expected average of 1 hour ]
    The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study.


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 by clinician
  • 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): NCT04064229


Locations
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United States, Virginia
ivWatch, LLC
Williamsburg, Virginia, United States, 23185
Sponsors and Collaborators
ivWatch, LLC
  Study Documents (Full-Text)

Documents provided by ivWatch, LLC:
Study Protocol and Statistical Analysis Plan  [PDF] March 12, 2019

More Information
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Responsible Party: ivWatch, LLC
ClinicalTrials.gov Identifier: NCT04064229    
Other Study ID Numbers: IVW-CLR-CS27-400
First Posted: August 21, 2019    Key Record Dates
Results First Posted: June 24, 2022
Last Update Posted: June 24, 2022
Last Verified: May 2022

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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