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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Device: Cortrium C3 device

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: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • University Medical Center Schleswig-Holstein, Campus Lübeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with cancer diagnose admitted to the hospital for treatment and/or monitoring of their health condition.

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

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer patients; Cancer patients admitted to hospital for treatment or monitoring of health condition	Device: Cortrium C3 device; Paired measurements of data from C3 device with golden standard methods or equipment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cortrium
• Collaborators: University College Absalon
• Investigators: Study Chair: Jacob Eric Nielsen, COO, Cortrium

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2017
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): September 26, 2019

Study Registration Dates

• First Submitted: April 30, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: December 6, 2019
• Last Verified: December 1, 2019

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)?: Yes
• IPD Plan Description: The data will be available for workflow design and nurse studies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No