ivWatch Model 400: Device Validation for Infiltrated Tissues
1 other identifier
interventional
71
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 28, 2014
CompletedResults Posted
Study results publicly available
June 27, 2014
CompletedJune 27, 2014
May 1, 2014
Same day
April 22, 2014
April 28, 2014
May 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Red Notification Sensitivity to Infiltrated Tissues
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.
After each participant has been infiltrated, an expected average of 1 hour
Secondary Outcomes (4)
Yellow Notification Sensitivity to Infiltrated Tissues
After each participant has been infiltrated, an expected average of 1 hour
Infiltrated Volume When Red Notification Issued
After each participant has been infiltrated, an expected average of 1 hour
Infiltrated Volume When Yellow Notification Issued
After each participant has been infiltrated, an expected average of 1 hour
Significant Skin Irritation or Disruption to Skin Integrity
After each participant has been infiltrated, an expected average of 1 hour
Study Arms (1)
Infiltrated Tissue
EXPERIMENTALThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Informed consent
- Pass health screen by clinician
- years or older
You may not qualify if:
- Fail health screen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ivWatch, LLClead
Study Sites (1)
ivWatch, LLC
Williamsburg, Virginia, 23185, United States
Results Point of Contact
- Title
- Garret T. Bonnema
- Organization
- ivWatch, LLC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2014
First Posted
April 28, 2014
Study Start
February 1, 2014
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
June 27, 2014
Results First Posted
June 27, 2014
Record last verified: 2014-05