Clinical Testing of the Cortrium C3 Device
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
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Germany, 23538
- University Medical Center Schleswig-Holstein, Campus Lübeck
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Cancer patients
Cancer patients admitted to hospital for treatment or monitoring of health condition
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Paired measurements of data from C3 device with golden standard methods or equipment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pulse rate
Time Frame: May 2017-March 2018
|
Continuous measurements from C3 device.
Punctual measurement observed by the healthcare personnel
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May 2017-March 2018
|
|
Respiratory rate
Time Frame: May 2017-March 2018
|
Continuous measurements from C3 device.
Punctual measurement observed by the
|
May 2017-March 2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
May 2017-March 2018
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Design & Workflow studies
Time Frame: May 2017-March 2018
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Observational studies and interviews with healthcare personnel and patients regarding the C3 device.
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May 2017-March 2018
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Jacob Eric Nielsen, COO, Cortrium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 94.1.05-5660-10728
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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