CancerNCT03387891
Clinical Testing of the Cortrium C3 Device
An observational study of Cancer, run by Cortrium at 1 site in Germany.
Trial summary
Clinical data validation of the C3 device as a Vital Sign Monitoring System for patients under cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Cortrium C3 device
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2017to 26 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cancer diagnose admitted to the hospital for treatment and/or monitoring of their health condition.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, 23538
About this study
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 data validation of the C3 device as a Vital Sign Monitoring System for patients under cancer treatment.
Read the 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.
- Conditions
- Cancer
- Being tested
- Cortrium C3 device
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortrium C3 deviceDevice
Paired measurements of data from C3 device with golden standard methods or equipment
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Cancer patients admitted to hospital for treatment or monitoring of health condition Receives: Device: Cortrium C3 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse rate
Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel
Measured: May 2017-March 2018
Respiratory rate
Continuous measurements from C3 device. Punctual measurement observed by the
Measured: May 2017-March 2018
Secondary outcomes (2)
Infection
Exploratory study - Comparison of all sensors embedded within the C3 device to the patient infection level (measured as fever)
Measured: May 2017-March 2018
Design & Workflow studies
Observational studies and interviews with healthcare personnel and patients regarding the C3 device.
Measured: May 2017-March 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start3 May 2017
- Primary completion12 Dec 2018
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortrium
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College Absalon
- Responsible party
- Sponsor
- Investigators
- Jacob Eric Nielsen, COO, Study chair, Cortrium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387891
- Sponsor's protocol ID
- 94.1.05-5660-10728
- Status last verified
- Dec 2019
- First submitted
- 30 Apr 2017
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available for workflow design and nurse studies.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03387891
- Acronym / sponsor ID
- 94.1.05-5660-10728
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CortriumIndustry (pharma, biotech, devices)
- Collaborators
- University College Absalon
- Study start
- 3 May 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | – | Device: Cortrium C3 deviceCancer patients admitted to hospital for treatment or monitoring of health condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cancer diagnose admitted to the hospital for treatment and/or monitoring of their health condition.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cortrium C3 devicePaired measurements of data from C3 device with golden standard methods or equipment | Device | Cancer patients |
Primary outcome
Pulse rate
Time frame: May 2017-March 2018
Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel
Respiratory rate
Time frame: May 2017-March 2018
Continuous measurements from C3 device. Punctual measurement observed by the
2 secondary outcomes
Infection
Time frame: May 2017-March 2018
Design & Workflow studies
Time frame: May 2017-March 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
- Individual participant dataSharing planned: Yes. The data will be available for workflow design and nurse studies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Eric Nielsen, COO study chair
Cortrium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Cortrium at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse rate (time frame: May 2017-March 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.