NCT02123745

ivWatch Model 400: Device Validation for Infiltrated Tissues

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: ivWatch, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.

Conditions

• Infiltration of Peripheral IV Therapy

Interventions

Type	Name	Description
DEVICE	The ivWatch Model 400	The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.

Timeline

• Start date: 2014-02-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-04-28
• Last updated: 2014-06-27
• Results posted: 2014-06-27

Locations

1 site across 1 country: United States