Clinical Testing of the Cortrium C3 Device

Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03387891
• Other study ID #: 94.1.05-5660-10728
• Status: Completed
• Start date: May 3, 2017
• Est. completion date: September 26, 2019

Study information

• Verified date: December 2019
• Source: Cortrium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 26, 2019
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Cortrium C3 device
Paired measurements of data from C3 device with golden standard methods or equipment

Locations

Country	Name	City	State
Germany	University Medical Center Schleswig-Holstein, Campus Lübeck	Lübeck	Schleswig-Holstein

Sponsors (2)

Lead Sponsor	Collaborator
Cortrium	University College Absalon

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse rate	Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel	May 2017-March 2018
Primary	Respiratory rate	Continuous measurements from C3 device. Punctual measurement observed by the	May 2017-March 2018
Secondary	Infection	Exploratory study - Comparison of all sensors embedded within the C3 device to the patient infection level (measured as fever)	May 2017-March 2018
Secondary	Design & Workflow studies	Observational studies and interviews with healthcare personnel and patients regarding the C3 device.	May 2017-March 2018