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

NCT02910479 | Completed Phase 1 DMC

• 1 other identifier: 14-167
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Body Temperature; Thermometers

Outcome Measures

Primary Outcomes (1)

• body temperature

  comparisons between device e-Celsius, esophageal probe and a rectal probe

  from baseline to 36 hours every minute

Secondary Outcomes (4)

• body temperature during ingestion of cold drinks

  baseline

• temperature of the digestive tract

  from baseline to 36 hours every minute

• number of lost data

  from baseline to 36 hours every minute

• reliability of measurements

  from baseline to 36 hours every minute

Study Arms (1)

temperature measurements with 4 devices

EXPERIMENTAL

temperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule

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

Interventions

Esophageal thermometer DEVICE

temperature measurements with 4 devices

Vital sense capsule thermometer DEVICE

temperature measurements with 4 devices

E-Celsius thermometer DEVICE

comparison of temperature between e-celsius and thermometer, rectal thermometer, esophageal thermometer, vital sense capsule thermometer

temperature measurements with 4 devices

Rectal thermometer DEVICE

temperature measurements with 4 devices

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers male or female (18 to 59 years inclusive)
• Signed the informed consent.
• Affiliated to the social security scheme
• French speaker

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Caen University Hospital

Caen, 14033, France

Location

Related Publications (1)

• Koumar OC, Beaufils R, Chesneau C, Normand H, Bessot N. Validation of e-Celsius gastrointestinal telemetry system as measure of core temperature. J Therm Biol. 2023 Feb;112:103471. doi: 10.1016/j.jtherbio.2023.103471. Epub 2023 Jan 9.

  PMID: 36796916 RESULT

MeSH Terms

Interventions

Thermometers

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: September 22, 2016
• Study Start: November 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 2, 2026

Record last verified: 2016-09

Locations

FR (1)