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A single arm trial consisting of 28 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 Milky Way 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivWatch Model 400 with Milky Way Sensor | Device | The ivWatch Model 400 with Milky Way 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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason Naramore, MS | Contact | (855) 489-2824 | jason.naramore@ivwatch.com | |
| Marisa Brown, BS | Contact | (855) 489-2824 | marisa.brown@ivwatch.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ivWatch | Newport News | Virginia | 23606 | United States |
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| 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. |