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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: E-Celsius thermometer; Device: Rectal thermometer; Device: Esophageal thermometer; Device: Vital sense capsule thermometer

• Registration Number: NCT02910479
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Study First Submitted: 2016-03-17
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-21
• Last Update Submitted: 2016-09-21
• Study First Posted: 2016-09-22
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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,)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
temperature measurements with 4 devices	Rectal thermometer	temperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule
temperature measurements with 4 devices	Esophageal thermometer	temperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule
temperature measurements with 4 devices	E-Celsius thermometer	temperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule
temperature measurements with 4 devices	Vital sense capsule thermometer	temperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule

Primary Outcome Measures

Name	Time	Method
body temperature	from baseline to 36 hours every minute	comparisons between device e-Celsius, esophageal probe and a rectal probe

Secondary Outcome Measures

Name	Time	Method
temperature of the digestive tract	from baseline to 36 hours every minute	Explore the thermal homogeneity of the digestive tract
number of lost data	from baseline to 36 hours every minute	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.
reliability of measurements	from baseline to 36 hours every minute	reliability of the measurement system while comparing it to the standards used by health staff today
body temperature during ingestion of cold drinks	baseline	Assess the effects of ingestion of cold drinks on temperature readings taken via e-device Celsius, esophageal probe and a rectal probe

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France