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Search / Trial NCT06942338

Comparative Evaluation of Body Temperature Measurement Using the CardioWatch 287-2 in an Intensive Care Setting.

Launched by CORSANO HEALTH B.V. · Apr 16, 2025

Trial Information

Current as of November 14, 2025

Not yet recruiting

Keywords

Wristband Wearable Body Temperature Validation Rectal Temperature Remote Monitoring

ClinConnect Summary

This clinical trial is studying a new device called the Corsano CardioWatch 287-2, which is a wristband that measures body temperature in a non-invasive way. Currently, many methods for checking temperature can be uncomfortable or expensive, and some are not continuous. The CardioWatch uses technology to track skin temperature and predict body temperature in real-time. Researchers want to see how accurately this wristband compares to the traditional method of taking temperature through the rectum, which is considered the gold standard in medical settings.

To participate in this trial, you need to be at least 18 years old and able to give your consent. Additionally, you must be a patient in the ICU or recovery room at the Reinier de Graaf hospital. However, if you have certain conditions, like skin issues that prevent you from wearing the wristband or if you have severe cognitive impairments, you may not be eligible. If you join the study, you'll help researchers understand if this new device can be a reliable way to monitor body temperature, which could improve care for patients in the ICU. Remember, the trial is not yet recruiting participants, so more information will be available once it starts.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ≥ 18 years old;
  • Able to provide consent
  • Administered at the ICU or recovery room of the Reinier de Graaf hospita
  • Exclusion Criteria:
  • Unable to wear the Corsano CardioWatch 287 or Radius-T sensor due to reasons such as allergic reactions, wounds, amputations etc.;
  • Unable to receive rectal temperature monitoring;
  • Thermoregulatory problems or diseases;
  • Hyperthermia (\>40°C);
  • Known allergy to plastics / latex;
  • Patient not willing to sign informed consent;
  • Significant mental or cognitive impairment.

About Corsano Health B.V.

Corsano Health B.V. is a pioneering clinical trial sponsor dedicated to advancing healthcare through innovative research and development. Specializing in the design and execution of clinical studies, Corsano Health leverages cutting-edge technologies and methodologies to enhance patient outcomes and drive efficiencies in the clinical trial process. With a commitment to ethical practices and regulatory compliance, the organization collaborates with various stakeholders, including healthcare professionals, research institutions, and biopharmaceutical companies, to bring transformative therapies to market. Corsano Health B.V. is at the forefront of improving clinical trial strategies, ultimately contributing to the evolution of personalized medicine.

Locations

Delft, Zuid Holland, Netherlands

Patients applied

0 patients applied

Trial Officials

Mariska van Vliet, MD, PhD

Principal Investigator

Reinier de Graaf Groep

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported