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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

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE August 21, 2019
Results First Submitted Date  ICMJE April 19, 2022
Results First Posted Date  ICMJE June 24, 2022
Last Update Posted Date June 24, 2022
Actual Study Start Date  ICMJE April 3, 2019
Actual Primary Completion Date April 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • 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.
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 Sensor: Device Validation for Infiltrated Tissues
Official Title  ICMJE ivWatch Sensor: Device Validation for Infiltrated Tissues
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.
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 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.
Study Arms  ICMJE 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.
Interventions:
  • Device: ivWatch Model 400 with SmartTouch Sensor
  • Device: ivWatch Model 400 with 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)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 9, 2019
Actual Primary Completion Date April 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Informed Consent
  • Pass health screen by clinician
  • 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 NCT04064229
Other Study ID Numbers  ICMJE IVW-CLR-CS27-400
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
Current Responsible Party ivWatch, LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ivWatch, LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ivWatch, LLC
Verification Date May 2022

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