Clinical Testing of the Cortrium C3 Device

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

Detailed Description
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Device: Cortrium C3 device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer patients<br>Cancer patients admitted to hospital for treatment or monitoring of health condition | Device: Cortrium C3 device<br>* Paired measurements of data from C3 device with golden standard methods or equipment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse rate | Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel | May 2017-March 2018 | 
| Respiratory rate | Continuous measurements from C3 device. Punctual measurement observed by the | May 2017-March 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | Exploratory study - Comparison of all sensors embedded within the C3 device to the patient infection level (measured as fever) | May 2017-March 2018 | 
| Design & Workflow studies | Observational studies and interviews with healthcare personnel and patients regarding the C3 device. | May 2017-March 2018 |