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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infiltrated Tissue | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivWatch Model 400 with SmartTouch Sensor | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Yellow Notification Sensitivity to Infiltrated Tissues | 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. | After each participant has been infiltrated, an expected average of 1 hour |
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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 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One case study (participant) was rejected and removed from analysis because there was a protocol error where the IV tubing was not properly connected, and the saline was leaked from the tubing rather than injected at the skin site.
| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| 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, Categorical | Count of Participants |
| 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 | 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. | Posted | Mean | 95% Confidence Interval | percentage of infiltrations detected | After each participant has been infiltrated, an expected average of 1 hour | IV Site | IV Site |
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A visual assessment of the skin was performed after completing each study. In addition, photos of the skin were captured before and after the study. The time frame of assessment was an expected average of 1 hour after each participant has been infiltrated.
Serious and other (non-serious) adverse events were assessed by the clinician performing the study.
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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 | SmartTouch Sensor | ivWatch Model 400 with SmartTouch sensor used to monitor IV site |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Naramore | ivWatch, LLC | 1-855-489-2824 | 7019 | jason.naramore@ivwatch.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 12, 2019 | Apr 19, 2022 | Prot_SAP_000.pdf |
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| ivWatch Model 400 with Fiber Optic Sensor | Device | 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. |
|
| Infiltrated Volume When Red Notification Issued | The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device. | After each participant has been infiltrated, an expected average of 1 hour |
| Infiltrated Volume When Yellow Notification Issued | The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device. | After each participant has been infiltrated, an expected average of 1 hour |
| Significant Skin Irritation or Disruption to Skin Integrity | The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study. | After each participant has been infiltrated, an expected average of 1 hour |
| IV Site |
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| Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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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 | Participants |
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| Body Mass Index (BMI) | BMI = 703 * weight (lb.) / (height (in.)^2) | Count of Participants | Participants | Participants |
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| Secondary | Yellow Notification Sensitivity to Infiltrated Tissues | 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. | Posted | Mean | 95% Confidence Interval | percentage of infiltrations detected | After each participant has been infiltrated, an expected average of 1 hour | IV SIte | IV SIte |
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| Secondary | Infiltrated Volume When Red Notification Issued | The amount of infiltrated isotonic saline solution when the red notification was issued by the ivWatch Model 400 device. | Posted | Median | Standard Deviation | mL | After each participant has been infiltrated, an expected average of 1 hour | IV Site | IV Site |
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| Secondary | Infiltrated Volume When Yellow Notification Issued | The amount of infiltrated isotonic saline solution when the yellow notification was issued by the ivWatch Model 400 device. | Posted | Median | Standard Deviation | mL | After each participant has been infiltrated, an expected average of 1 hour | IV Site | IV Site |
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| Secondary | Significant Skin Irritation or Disruption to Skin Integrity | The number of IV sites that indicated significant skin irritation or disruption to skin integrity assessed at the end of the study. | Posted | Count of Units | IV Site | After each participant has been infiltrated, an expected average of 1 hour | IV Site | IV Site |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Fiber Optic Sensor | ivWatch Model 400 with Fiber Optic sensor used to monitor IV site | 0 | 99 | 0 | 99 | 0 | 99 |
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