Healthy Volunteers Clinical Trial
Official title:
Phase 1 Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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