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
1 other identifier
observational
21
1 country
1
Brief Summary
Clinical data validation of the C3 device as a Vital Sign Monitoring System for patients under cancer treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2017
CompletedStudy Start
First participant enrolled
May 3, 2017
CompletedFirst Posted
Study publicly available on registry
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 26, 2019
CompletedDecember 9, 2019
December 1, 2019
1.6 years
April 30, 2017
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Infection
May 2017-March 2018
Design & Workflow studies
May 2017-March 2018
Study Arms (1)
Cancer patients
Cancer patients admitted to hospital for treatment or monitoring of health condition
Interventions
Paired measurements of data from C3 device with golden standard methods or equipment
Eligibility Criteria
Patients with cancer diagnose admitted to the hospital for treatment and/or monitoring of their health condition.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cortriumlead
- University College Absaloncollaborator
Study Sites (1)
University Medical Center Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, 23538, Germany
MeSH Terms
Conditions
Study Officials
- STUDY CHAIR
Jacob Eric Nielsen, COO
Cortrium
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2017
First Posted
January 2, 2018
Study Start
May 3, 2017
Primary Completion
December 12, 2018
Study Completion
September 26, 2019
Last Updated
December 9, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will share
The data will be available for workflow design and nurse studies.