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ivWatch Sensor: Device Validation for Infiltrated Tissues

NCT04064229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2022-06-24

Study results available
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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

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.

Sponsors & Collaborators

  • ivWatch, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-03
Primary Completion
2019-04-09
Completion
2019-04-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04064229 on ClinicalTrials.gov