Clinical Testing of the Cortrium C3 Device

December 6, 2019 updated by: Cortrium

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

Intervention / 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 Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

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
Time Frame: May 2017-March 2018
Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel
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
Design & Workflow studies
Time Frame: May 2017-March 2018
Observational studies and interviews with healthcare personnel and patients regarding the C3 device.
May 2017-March 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cortrium

Collaborators

University College Absalon

Investigators

  • Study Chair: Jacob Eric Nielsen, COO, Cortrium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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