Clinical Testing of the Cortrium C3 Device

Completed

• Conditions: Cancer
• Interventions: Device: Cortrium C3 device

• Registration Number: NCT03387891
• Lead Sponsor: Cortrium

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-04-30
• Study Start: 2017-05-03
• Study First Submitted QC: 2017-12-22
• Study First Posted: 2018-01-02
• Primary Completion: 2018-12-12
• Study Completion: 2019-09-26
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer patients	Cortrium C3 device	Cancer patients admitted to hospital for treatment or monitoring of health condition

Primary Outcome Measures

Name	Time	Method
Respiratory rate	May 2017-March 2018	Continuous measurements from C3 device. Punctual measurement observed by the
Pulse rate	May 2017-March 2018	Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Schleswig-Holstein, Campus Lübeck; 🇩🇪 Lübeck, Schleswig-Holstein, Germany