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

Healthy Volunteers Clinical Trial

— e-TEMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910479
• Other study ID #: 14-167
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2016
• Last updated: September 21, 2016
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• E-Celsius thermometer
comparison of temperature between e-celsius and thermometer, rectal thermometer, esophageal thermometer, vital sense capsule thermometer
• Rectal thermometer

• Esophageal thermometer

• Vital sense capsule thermometer

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Caen	Institut National de la Santé Et de la Recherche Médicale, France, La Région Basse-Normandie, Université de Caen Normandie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body temperature	comparisons between device e-Celsius, esophageal probe and a rectal probe	from baseline to 36 hours every minute	No
Secondary	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	No
Secondary	temperature of the digestive tract	Explore the thermal homogeneity of the digestive tract	from baseline to 36 hours every minute	No
Secondary	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	No
Secondary	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	No