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ivWatch Model 400: 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: NCT02120443
Recruitment Status : Completed
First Posted : April 22, 2014
Results First Posted : June 23, 2014
Last Update Posted : July 2, 2014
Sponsor:
Information provided by (Responsible Party):
Garret Bonnema, ivWatch, LLC

Tracking Information
First Submitted Date  ICMJE April 18, 2014
First Posted Date  ICMJE April 22, 2014
Results First Submitted Date  ICMJE April 22, 2014
Results First Posted Date  ICMJE June 23, 2014
Last Update Posted Date July 2, 2014
Study Start Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
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 the Clopper-Pearson method.
Original Primary Outcome Measures  ICMJE
 (submitted: April 18, 2014)
False Red Notification Rate [ Time Frame: 24 hours ]
A measure for how often false red notifications are issued for subjects with normal (non-infiltrated) tissue.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2014)
  • 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 the Clopper-Pearson method.
  • 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
 (submitted: April 18, 2014)
  • False Yellow Notification Rate [ Time Frame: 24 hours ]
    A measure for how often false yellow notifications are issued for subjects with normal (non-infiltrated) tissue.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
Official Title  ICMJE ivWatch Model 400: 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 Model 400 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
The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.
Study Arms  ICMJE Experimental: Non-Infiltrated Tissue
The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.
Intervention: Device: ivWatch Model 400
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: April 18, 2014)
43
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (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 NCT02120443
Other Study ID Numbers  ICMJE IVW400CS-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Garret Bonnema, ivWatch, LLC
Study Sponsor  ICMJE ivWatch, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ivWatch, LLC
Verification Date June 2014

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