ivWatch Model 400: Device Validation for Non-Infiltrated Tissues
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ClinicalTrials.gov Identifier: NCT02120443 |
Recruitment Status :
Completed
First Posted : April 22, 2014
Results First Posted : June 23, 2014
Last Update Posted : July 2, 2014
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Sponsor:
ivWatch, LLC
Information provided by (Responsible Party):
Garret Bonnema, ivWatch, LLC
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic |
Condition |
Infiltration of Peripheral IV Therapy |
Intervention |
Device: ivWatch Model 400 |
Enrollment | 43 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Non-Infiltrated Tissue |
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The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period. |
Period Title: Overall Study | |
Started | 43 |
Completed | 43 |
Not Completed | 0 |
Baseline Characteristics
Arm/Group Title | Non-Infiltrated Tissue | |
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The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period. |
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Overall Number of Baseline Participants | 43 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 43 participants | |
31.4 (13.9) | ||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 43 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
42 97.7%
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>=65 years |
1 2.3%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 43 participants | |
Female |
18 41.9%
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Male |
25 58.1%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 43 participants |
43 | ||
Body Mass Index
Mean (Standard Deviation) Unit of measure: Kg/m^2 |
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Number Analyzed | 43 participants | |
26.3 (5.4) | ||
Skin Pigmentation
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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Number Analyzed | 43 participants | |
1.84 (0.84) | ||
[1]
Measure Description: Skin pigmentation was scored from 1 to 3 where 1 represents light skin pigmentation, 2 represents medium skin pigmentation, and 3 represents dark skin pigmentation.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Garret T. Bonnema |
Organization: | ivWatch, LLC |
Phone: | 1.855.489.2824 ext 7018 |
EMail: | garret.bonnema@ivwatch.com |
Responsible Party: | Garret Bonnema, ivWatch, LLC |
ClinicalTrials.gov Identifier: | NCT02120443 |
Other Study ID Numbers: |
IVW400CS-05 |
First Submitted: | April 18, 2014 |
First Posted: | April 22, 2014 |
Results First Submitted: | April 22, 2014 |
Results First Posted: | June 23, 2014 |
Last Update Posted: | July 2, 2014 |