- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04064229
ivWatch Sensor: Device Validation for Infiltrated Tissues
May 31, 2022 updated by: ivWatch, LLC
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Williamsburg, Virginia, United States, 23185
- ivWatch, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed Consent
- Pass health screen by clinician
- 18 years or older
Exclusion Criteria:
- Fail health screen
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Red Notification Sensitivity to Infiltrated Tissues
Time Frame: After each participant has been infiltrated, an expected average of 1 hour
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yellow Notification Sensitivity to Infiltrated Tissues
Time Frame: After each participant has been infiltrated, an expected average of 1 hour
|
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
|
Infiltrated Volume When Red Notification Issued
Time Frame: After each participant has been infiltrated, an expected average of 1 hour
|
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
Time Frame: After each participant has been infiltrated, an expected average of 1 hour
|
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
Time Frame: After each participant has been infiltrated, an expected average of 1 hour
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 3, 2019
Primary Completion (ACTUAL)
April 9, 2019
Study Completion (ACTUAL)
April 9, 2019
Study Registration Dates
First Submitted
August 20, 2019
First Submitted That Met QC Criteria
August 20, 2019
First Posted (ACTUAL)
August 21, 2019
Study Record Updates
Last Update Posted (ACTUAL)
June 24, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- IVW-CLR-CS27-400
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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