Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Phase 1 Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Device: E-Celsius thermometer
* Device: Rectal thermometer
* Device: Esophageal thermometer
* Device: Vital sense capsule thermometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers male or female (18 to 59 years inclusive) Signed the informed consent. Affiliated to the social security scheme French speaker Exclusion Criteria: Subject having started or stopped during the 15 days preceding the inclusion visit one of the following treatments: antidepressants, anxiolytics, antiparkinsonian agents, neuroleptics. Subject having taken over the previous 7 days a drug to treat irritable bowel syndrome (antispasmodic, etc ...) or constipation (laxative) Subject with known food allergies Subject undergoing surgery for colon surgery Subject with an organic occlusion Subject with known abnormal liver or renal function Subject participating in another clinical study within a month before the inclusion visit. A person with a bodyweight under 40 kg Any person with obstruction (known or suspected) of the gastrointestinal tract, including people with diverticula (folds) intestinal or intestinal inflammation known. People with a BMI greater than or equal to 30. People under guardianship People who have or had known swallowing disorders People who have to undergo an MRI or to be subjected to a strong magnetic field programmed during the transit of the capsule Persons equipped with a pacemaker People with diabetes or with diabetic history People with heave The detainees Pregnant women People with nasal septum deviation People with against-indications to the placement of an esophageal tube: people who carry chronic esophageal pathology (eg, gastroesophageal reflux treated, hiatal hernia,)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: temperature measurements with 4 devices<br>temperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule | Device: E-Celsius thermometer<br>* comparison of temperature between e-celsius and thermometer, rectal thermometer, esophageal thermometer, vital sense capsule thermometer<br>Device: Rectal thermometer<br> <br> Device: Esophageal thermometer<br> <br> Device: Vital sense capsule thermometer<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body temperature | comparisons between device e-Celsius, esophageal probe and a rectal probe | from baseline to 36 hours every minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body temperature during ingestion of cold drinks | Assess the effects of ingestion of cold drinks on temperature readings taken via e-device Celsius, esophageal probe and a rectal probe | baseline | 
| temperature of the digestive tract | Explore the thermal homogeneity of the digestive tract | from baseline to 36 hours every minute | 
| number of lost data | The capacity of the for each measurements method to store temperature data in the internal memory and send it to the receiver when the it is in the receiving area. | from baseline to 36 hours every minute | 
| reliability of measurements | reliability of the measurement system while comparing it to the standards used by health staff today | from baseline to 36 hours every minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Body Temperature, Thermometers