Feasibility of Wearable-Based Continuous Temperature Monitoring

Exclusion Criteria

• •General:
• •Body weight \< 36 kg.
• •Women who are pregnant.
• •Participation in another clinical investigation involving an investigational medicinal product or medical device within the 30 days preceding enrolment or previous enrolment in the current project.
• •Enrolment of the Principal Investigator, project staff, their family members, employees, or other dependent persons.
• •Inability to provide valid informed consent or significant language barrier preventing adequate understanding of procedures.
• •Implants \& MRI:
• •Presence of any active Implantable Medical Device (AIMD), including Pacemakers, Implantable Cardioverter Defibrillators (ICDs), Deep Brain Stimulation (DBS) devices, or Left Ventricular Assist Devices (LVADs).
• •Requirement for MRI scanning during the seven days following the capsule intake.
• •Cognitive/Physical Status:
• •Unconscious patients (prior to ingestion).
• •Patients with special needs or disabilities preventing safe autonomous swallowing.
• •Gastrointestinal:
• •Known history of dysphagia or gag reflex troubles.
• •Previous gastrointestinal surgery resulting in bowel stenosis.
• •Current or planned surgical procedures on the GI tract (esophagus, stomach, intestines).
• •Zenker's diverticulum or felinization of the esophagus.
• •Risk or history of intestinal obstruction, strictures, or diverticula.
• •Hypomotility disorders (e.g., ileus).
• •Inflammatory Bowel Diseases including Crohn's disease or Ulcerative Colitis.
• •Dermatological Exclusions (Rheo Vital+ Performance)
• •Dermatological conditions, wounds, tattoos, oedema, inflammation, active venous access, or other impairments at the medial upper arm or axillary region that could interfere with correct placement or functioning of the wearable device.
• •Excessive hair or concurrent devices that hinder correct sensor placement.
• •Known allergy to plastics or latex.
• •Temperature Management:
• •Active external heating or cooling (e.g., cooling blankets).
• •Note: Use of pharmacological antipyretics (oral/IV) is permitted.
• •Further Medical Conditions:
• •Currently existing acute back pain.
• •Symptomatic herniated disc.