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ivWatch SmartTouch Sensor: Device Validation for Non-Infiltrated Tissues

NCT04065373 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2019-08-22

No results posted yet for this study

Summary

A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch SmartTouch and fiber optic sensors when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.

Conditions

  • Infiltration of Peripheral IV Therapy

Interventions

DEVICE

ivWatch Model 400 with SmartTouch and fiber optic sensor

The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored tissue at common IV sites over a 24 hour period.

Sponsors & Collaborators

  • ivWatch, LLC

    lead INDUSTRY

Principal Investigators

  • Marisa Cole · Employee

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2019-06-21
Completion
2019-06-21
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 NCT04065373 on ClinicalTrials.gov