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Completed

NCT Number: NCT04064229

ivWatch Sensor: Device Validation for Infiltrated Tissues

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.

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Key information

Conditions

Infiltration of Peripheral IV Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ivWatch, LLC

Williamsburg, Virginia, 23185, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed Consent
  • Pass health screen by clinician
  • 18 years or older

Exclusion criteria

  • Fail health screen

Treatment and study plan

ivWatch Model 400 with SmartTouch Sensor

Device

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

Device

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

ivWatch, LLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 21, 2019
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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