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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Infiltrated Tissue | Experimental | The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivWatch Model 400 | Device | The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Normal Tissue Red Notification Rate | 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Normal Tissue Yellow Notification Rate | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ivWatch, LLC | Williamsburg | Virginia | 23185 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Non-Infiltrated Tissue | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-Infiltrated Tissue | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Normal Tissue Red Notification Rate | 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. | Three subjects were excluded from analysis due to significant protocol deviations. | Posted | Mean | 95% Confidence Interval | red notifications per day | 24 hours |
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Adverse events were collected during the individual studies (approximately 24 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-Infiltrated Tissue | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Garret T. Bonnema | ivWatch, LLC | 1.855.489.2824 | 7018 | garret.bonnema@ivwatch.com |
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| 24 hours |
| Significant Skin Irritation or Disruption to Skin Integrity | 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. | 24 hours |
| years |
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Skin Pigmentation | 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. | Mean | Standard Deviation | units on a scale |
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| Secondary | Normal Tissue Yellow Notification Rate | 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. | Three participants were excluded due to significant protocol deviations. | Posted | Mean | 95% Confidence Interval | yellow notifications per day | 24 hours |
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| Secondary | Significant Skin Irritation or Disruption to Skin Integrity | 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. | Three participants were excluded for significant protocol deviations. | Posted | Number | 95% Confidence Interval | IV sites | 24 hours |
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