NCT04064229

ivWatch Sensor: Device Validation for Infiltrated Tissues

Completed NA Results posted Last updated 24 June 2022

What this trial tests

NA trial testing ivWatch Model 400 with SmartTouch Sensor in Infiltration of Peripheral IV Therapy in 99 participants. Completed in 9 April 2019.

Timeline

3 April 2019

Primary endpoint
9 April 2019

9 April 2019

Quick facts

Lead sponsor	ivWatch, LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	99
Start date	3 April 2019
Primary completion	9 April 2019
Estimated completion	9 April 2019
Sites	1 location across United States

Drugs / interventions tested

• ivWatch Model 400 with SmartTouch Sensor
• ivWatch Model 400 with Fiber Optic Sensor

Conditions studied

• Infiltration of Peripheral IV Therapy — all drugs for Infiltration of Peripheral IV Therapy →

Sponsor

ivWatch, LLC

Who can join

18 and older, any sex, with Infiltration of Peripheral IV Therapy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Red Notification Sensitivity to Infiltrated Tissues Primary · 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.

Group	Value	95% CI
SmartTouch Sensor	99.0	94.5 – 100.0
Fiber Optic Sensor	99.0	94.5 – 100.0

Yellow Notification Sensitivity to Infiltrated Tissues Secondary · 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.

Group	Value	95% CI
SmartTouch Sensor	99.0	94.5 – 100.0
Fiber Optic Sensor	99.0	94.5 – 100.0

Infiltrated Volume When Red Notification Issued Secondary · 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.

Group	Value	95% CI
SmartTouch Sensor	1.75	± 1.45
Fiber Optic Sensor	4.33	± 2.11

Infiltrated Volume When Yellow Notification Issued Secondary · 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.

Group	Value	95% CI
SmartTouch Sensor	1.66	± 1.39
Fiber Optic Sensor	3.90	± 1.89

Significant Skin Irritation or Disruption to Skin Integrity Secondary · 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.

Group	Value	95% CI
SmartTouch Sensor	0
Fiber Optic Sensor	0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.