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Completed

NCT Number: NCT03387891

Clinical Testing of the Cortrium C3 Device

Clinical data validation of the C3 device as a Vital Sign Monitoring System for patients under cancer treatment.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Schleswig-Holstein, Campus Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

About this study

Cortrium has developed the C3 device. The C3 device contains sensors that monitors Electrocardiogram (ECG), Respiratory rate (breathes per minute), and Body surface temperature. Also, the C3 device contains an accelerometer for registration of the body posture.

The following thesis will be tested:

Thesis 1) Pulse: The C3 device produces clinically validated pulse data. Thesis 2) Respiratory rate: The C3 device produces clinically validated respiratory rate data (breaths per minute). Thesis 3) Infection: With no justified statistical significant correlation between skin and body temperature, the study is exploring how to prevent aggravated or lethal outcomes of cancer treatment, e.g. chemotherapy, by using vital signs measurements combined with accelerometer data to detect infection levels. Thesis 4) The qualitative study: The study will report the advantages and disadvantages regarding new technological solutions, and the change in workflow and healthcare provision as it is experienced by the healthcare personnel and the patients. The data validation studies (thesis 1-3) will be tested in comparison with golden standard measurements methods and/or data validated medical equipment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Legally competent persons - i.e., patients considered able to understand the information given about the clinical trial
  • Person is 18 years or older
  • Person has given a written informed consent

Exclusion criteria

  • Not legally competent patients
  • Pregnant and lactating women
  • Fertile women, who do not use contraceptives
  • Patients under 18 years
  • Patients with known heart-related disease

Treatment and study plan

Cortrium C3 device

Device

Paired measurements of data from C3 device with golden standard methods or equipment

Primary outcomes

  1. Pulse rate

    Time frame: May 2017-March 2018

    Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel

  2. Respiratory rate

    Time frame: May 2017-March 2018

    Continuous measurements from C3 device. Punctual measurement observed by the

Secondary outcomes

  1. Infection

    Time frame: May 2017-March 2018

    Exploratory study - Comparison of all sensors embedded within the C3 device to the patient infection level (measured as fever)

  2. Design & Workflow studies

    Time frame: May 2017-March 2018

    Observational studies and interviews with healthcare personnel and patients regarding the C3 device.

Sponsors and collaborators

Lead sponsor

Cortrium

Industry

Collaborators

  • University College Absalon

Registry information

Official study title

Clinical Testing on Newly Developed Monitoring Technology (The Cortrium C3 Device) for Continuous Measurements of ECG, Respiratory Rate, Body Surface Temperature and Accelerometer Data for Patients With Cancer

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 2, 2018
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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