E-NOSE for Breath Gas Analysis Under Microgravity Conditions | NCT02507622

Studies
E-NOSE for Breath Gas Analysis Under Microgravity Conditions

NCT02507622

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

Jul 24, 2015Estimated

Enrollment

18Estimated

Phase

Not Applicable

Conditions

Healthy Volunteers

Interventions

measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system
Parabolic flight

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Nov 2017Estimated

Completion Date

Nov 2017Estimated

First Submitted Date

Jul 21, 2015

First Submission Date that Met QC Criteria

Jul 23, 2015

First Posted Date

Jul 24, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2015

Last Update Posted Date

Jul 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
gas concentration	Other	Gaz concentration of C02, CO and NH4, 3 exhaled in weightlessness and normal gravity.	Other: measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system Other: Parabolic flight

Interventions

Name	Type	Description	Arm Group Labels	Other Names
measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system	Other		gas concentration
Parabolic flight

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The judgment criteria are the concentration of C02, CO and NH4, 3 exhaled gas		baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Umr Ucbn/Inserm U1075 Comete	Recruiting	Caen	Basse-Normandie	14032	France