At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Informed consent obtained
- ✓Pass health screen by clinician
- ✕Fail health screen by clinician
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
ivWatch Sensor: Device Validation for Infiltrated Tissues
In Brief
A clinical study evaluating ivWatch Model 400 with SmartTouch Sensor and ivWatch Model 400 with Fiber Optic Sensor for Infiltration of Peripheral IV Therapy. Completed, enrolled 99 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.