NCT04064229

ivWatch Sensor: Device Validation for Infiltrated Tissues

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: ivWatch, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Infiltration of Peripheral IV Therapy

Interventions

Type	Name	Description
DEVICE	ivWatch Model 400 with SmartTouch Sensor	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.
DEVICE	ivWatch Model 400 with Fiber Optic Sensor	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.

Timeline

• Start date: 2019-04-03
• Primary completion: 2019-04-09
• Completion: 2019-04-09
• First posted: 2019-08-21
• Last updated: 2022-06-24
• Results posted: 2022-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study