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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: E-Celsius thermometer; Device: Rectal thermometer; Device: Esophageal thermometer; Device: Vital sense capsule thermometer

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • CAEN University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; La Région Basse-Normandie; Université de Caen Normandie

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: March 17, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 22, 2016

Study Record Updates

• Last Update Posted (Estimate): September 22, 2016
• Last Update Submitted That Met QC Criteria: September 21, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Body Temperature; Thermometers
• Other Study ID Numbers: 14-167

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No