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ivWatch SmartTouch Sensor: Device Validation for Non-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: NCT04065373
Recruitment Status : Completed
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
ivWatch, LLC

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE April 25, 2019
Actual Primary Completion Date June 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues
Official Title  ICMJE ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Infiltration of Peripheral IV Therapy
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: ivWatch Model 400 with SmartTouch and fiber optic sensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 20, 2019)
45
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 21, 2019
Actual Primary Completion Date June 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Fail health screen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04065373
Other Study ID Numbers  ICMJE IVW-CLR-CS24-400
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ivWatch, LLC
Study Sponsor  ICMJE ivWatch, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Marisa Cole Employee
PRS Account ivWatch, LLC
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP