Healthy VolunteersPhase 1e-TEMPNCT02910479
Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)
A Phase 1 study testing E-Celsius thermometer, Rectal thermometer and Esophageal thermometer in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- E-Celsius thermometer, Rectal thermometer and Esophageal thermometer
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers male or female (18 to 59 years inclusive)
- Signed the informed consent.
- Affiliated to the social security scheme
- French speaker
Who cannot join
- 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
Show all 20Show fewer
- 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,)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- E-Celsius thermometer, Rectal thermometer, Esophageal thermometer, Vital sense capsule thermometer
- Keywords
- Body Temperature, Thermometers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-Celsius thermometerDevice
comparison of temperature between e-celsius and thermometer, rectal thermometer, esophageal thermometer, vital sense capsule thermometer
Rectal thermometerDevice
Esophageal thermometerDevice
Vital sense capsule thermometerDevice
| Study group | Role | What they receive |
|---|---|---|
| temperature measurements with 4 devices | Experimental | temperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule Receives: Device: E-Celsius thermometer; Device: Rectal thermometer; Device: Esophageal thermometer; Device: Vital sense capsule thermometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
body temperature
comparisons between device e-Celsius, esophageal probe and a rectal probe
Measured: from baseline to 36 hours every minute
Secondary outcomes (4)
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
Measured: baseline
temperature of the digestive tract
Explore the thermal homogeneity of the digestive tract
Measured: 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.
Measured: 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
Measured: from baseline to 36 hours every minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startNov 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, La Région Basse-Normandie, Université de Caen Normandie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910479
- Sponsor's protocol ID
- 14-167
- Acronym
- e-TEMP
- Status last verified
- Sep 2016
- First submitted
- 17 Mar 2016
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36796916
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study Evaluating the Relevance and Reliability of Gastrointestinal Temperature Measurements From a New Device (E-celsius)
- ClinicalTrials.gov ID
- NCT02910479
- Acronym / sponsor ID
- e-TEMP / 14-167
- Conditions
- Healthy Volunteers
- Keywords
- Body Temperature, Thermometers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, La Région Basse-Normandie, Université de Caen Normandie
- Study start
- Nov 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| temperature measurements with 4 devices | Experimental | Device: E-Celsius thermometer, Device: Rectal thermometer, Device: Esophageal thermometer, Device: Vital sense capsule thermometertemperature measurements with e-device Celsius, esophageal probe and a rectal probe and vital sense capsule |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers male or female (18 to 59 years inclusive)
- Signed the informed consent.
- Affiliated to the social security scheme
- French speaker
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-Celsius thermometercomparison of temperature between e-celsius and thermometer, rectal thermometer, esophageal thermometer, vital sense capsule thermometer | Device | temperature measurements with 4 devices |
| Rectal thermometer | Device | temperature measurements with 4 devices |
| Esophageal thermometer | Device | temperature measurements with 4 devices |
| Vital sense capsule thermometer | Device | temperature measurements with 4 devices |
Primary outcome
body temperature
Time frame: from baseline to 36 hours every minute
comparisons between device e-Celsius, esophageal probe and a rectal probe
4 secondary outcomes
body temperature during ingestion of cold drinks
Time frame: baseline
temperature of the digestive tract
Time frame: from baseline to 36 hours every minute
number of lost data
Time frame: from baseline to 36 hours every minute
reliability of measurements
Time frame: from baseline to 36 hours every minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 36796916Koumar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing E-Celsius thermometer, Rectal thermometer and Esophageal thermometer in people with Healthy Volunteers, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body temperature (time frame: from baseline to 36 hours every minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.