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You can access this
clinical trial
if you have
Healthy Volunteers
and you are
between 18 and 59
years old
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

E-Celsius device used for measuring the gastrointestinal temperature is composed of an ingestible capsule measuring the temperature as well as a transportable module receiving data from the capsule. This device allows to measure the body temperature (± 0.2 ° C) during transit of the pill in the digestive tract to a maximum sampling frequency of 30 seconds. The main risks related to such devices are related to biocompatibility (in materials used for the capsule shell, or level of contamination of the gastrointestinal environment due to a defect in the plastic envelope the pill or a lack of hygiene, previously tested in clinical trials; see section 10.2). It will compare conventional methods of estimating the central temperature continuously with gastrointestinal data obtained from the e-Celsius device. The main objective of the research is to validate the extent of gastrointestinal temperature obtained from the device under test consists of an ingestible electronic capsule and a data reception monitor. Secondary objectives will be pursued: - Assess the effects of ingestion of cold drinks on temperature readings taken via e-device Celsius, esophageal probe and a rectal probe. - Explore the thermal homogeneity of the digestive tract. - Evaluate the internal memory of the capsule and its data forwarding capacity. This protocol will also measure the reliability of the measurement system while comparing it to the standards used by health staff today.

Provided treatments

  • Device: E-Celsius thermometer
  • Device: Rectal thermometer
  • Device: Esophageal thermometer
  • Device: Vital sense capsule thermometer

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02910479. The sponsor of the trial is University Hospital, Caen and it is looking for 22 volunteers for the current phase.
Official trial title:
Phase 1 Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)