- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507622
E-NOSE for Breath Gas Analysis Under Microgravity Conditions (E-NOSE)
July 23, 2015 updated by: University Hospital, Caen
The main goal of the study is demonstrate that e-Nose system function is not altered in weightlessness and more specifically that gas concentration measurements are the same in weightlessness and normal gravity.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basse-Normandie
-
Caen CEDEX, Basse-Normandie, France, 14032
- Recruiting
- Umr Ucbn/Inserm U1075 Comete
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy volunteers (men or women)
- Aged from 20 to 65
- Affiliated to a French Social Security system or, for people living abroad, holding a European Health Insurance Card (EHIC)
- Who accepted to take part in the study
- Who has given their written stated consent
- Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude (JAR FCL3 Class 2 medical examination). There will be no additional test performed for subject selection
Exclusion Criteria:
- Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: gas concentration
Gaz concentration of C02, CO and NH4, 3 exhaled in weightlessness and normal gravity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The judgment criteria are the concentration of C02, CO and NH4, 3 exhaled gas
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2014
Primary Completion (Anticipated)
November 1, 2017
Study Completion (Anticipated)
November 1, 2017
Study Registration Dates
First Submitted
July 21, 2015
First Submitted That Met QC Criteria
July 23, 2015
First Posted (Estimate)
July 24, 2015
Study Record Updates
Last Update Posted (Estimate)
July 24, 2015
Last Update Submitted That Met QC Criteria
July 23, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 14-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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