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ivWatch Model 400: Device Validation for Infiltrated Tissues

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ClinicalTrials.gov Identifier: NCT02123745
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Information provided by (Responsible Party):
ivWatch, LLC

April 22, 2014
April 28, 2014
April 28, 2014
June 27, 2014
June 27, 2014
February 2014
February 2014   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02123745 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
  • 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.
Same as current
Not Provided
Not Provided
 
ivWatch Model 400: Device Validation for Infiltrated Tissues
Not Provided
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Infiltration of Peripheral IV Therapy
Device: The ivWatch Model 400
The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
Experimental: Infiltrated Tissue
The ivWatch Model 400 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.
Intervention: Device: The ivWatch Model 400
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
Same as current
February 2014
February 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Fail health screen
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02123745
IVW400CS-06
Yes
Not Provided
Not Provided
ivWatch, LLC
ivWatch, LLC
Not Provided
Not Provided
ivWatch, LLC
May 2014

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