ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04065373 |
Recruitment Status :
Completed
First Posted : August 22, 2019
Last Update Posted : August 22, 2019
|
- Study Details
- Tabular View
- Results Submitted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infiltration of Peripheral IV Therapy | Device: ivWatch Model 400 with SmartTouch and fiber optic sensor | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues |
Actual Study Start Date : | April 25, 2019 |
Actual Primary Completion Date : | June 21, 2019 |
Actual Study Completion Date : | June 21, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Non-Infiltrated Tissue
The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored a common peripheral IV site over a 24 hour observation period.
|
Device: ivWatch Model 400 with SmartTouch and fiber optic sensor
The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored tissue at common IV sites over a 24 hour period. |
- Normal Tissue Red Notification Rate [ Time Frame: 24 Hours ]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 a negative binomial regression model.
- Normal Tissue Yellow Notification Rate [ Time Frame: 24 Hours ]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 a negative binomial regression model.
- Significant Skin Irritation or Disruption to Skin Integrity [ Time Frame: 24 Hours ]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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Informed consent
- Pass health screen
- 18 years or older
Exclusion Criteria:
- Fail health screen

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065373
United States, Virginia | |
ivWatch, LLC | |
Williamsburg, Virginia, United States, 23185 |
Study Director: | Marisa Cole | Employee |
Responsible Party: | ivWatch, LLC |
ClinicalTrials.gov Identifier: | NCT04065373 |
Other Study ID Numbers: |
IVW-CLR-CS24-400 |
First Posted: | August 22, 2019 Key Record Dates |
Last Update Posted: | August 22, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Product Manufactured in and Exported from the U.S.: | No |