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Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018

NCT06056011 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 373

Last updated 2026-03-11

Study results available
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Summary

The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.

Conditions

  • Febrile Illness

Interventions

DEVICE

Connex CVSM with Timmy3 module

Connex Vital Signs Monitor with the Timmy3 Investigational module

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Eric Fernandez, M.D. · Baxter Healthcare Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Day
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-19
Primary Completion
2025-03-18
Completion
2025-03-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06056011 on ClinicalTrials.gov