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NCT number NCT03387891
Study type Observational
Source Cortrium
Contact Dirk Rades Prof. Dr. med
Phone +49-451 500 45400
Status Recruiting
Phase N/A
Start date May 3, 2017
Completion date June 30, 2018

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

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