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Clinical Testing of the Cortrium C3 Device

C

Cortrium

Status

Completed

Conditions

Cancer

Treatments

Device: Cortrium C3 device

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03387891
94.1.05-5660-10728

Details and patient eligibility

About

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

Full 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.

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

21 participants in 1 patient group

Cancer patients
Description:
Cancer patients admitted to hospital for treatment or monitoring of health condition
Treatment:
Device: Cortrium C3 device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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