Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 1:32 AM
Study NCT ID:
NCT03992651
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2019-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optical Transcutaneous Sensors of Capnia and Oxygenation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2019-06-17', 'studyFirstSubmitQcDate': '2019-06-19', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of capnia values', 'timeFrame': 'Continuous measurement during the only experimental session (1 hour)', 'description': 'Comparison of capnia values measured by the new sensors and the standard laboratory sensors'}], 'secondaryOutcomes': [{'measure': 'Comparison of tissue oxygenation values', 'timeFrame': 'Continuous measurement during the only experimental session (1 hour)', 'description': 'Comparison of tissue oxygenation values measured by the new sensors and the standard laboratory sensors'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Gas Monitoring, Transcutaneous']}, 'descriptionModule': {'briefSummary': 'This study aims at validating new optical transcutaneous sensors to evaluate tissue capnia (CO2 partial pressure) and oxygenation (blood oxygen saturation) by comparing them to standard laboratory measurements (end tidal CO2 measurements and oxygen saturation by near-infrared spectroscopy).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females between 18 and 50 year old\n* Individual having health insurance\n* Individual able to provided informed consent\n* Subjects with no known pathology and not taking any medical treatment a priori capable of interfering with controlled hypoxia at levels required in the protocol\n\nExclusion Criteria:\n\n* Body mass index \\>27 kg/m²\n* History of acute mountain sickness\n* Chronic diseases know to be associated with high methemoglobinemia\n* Known allergy to one of the materials used in the devices (lycra, polyamide...), or to the adhesive plaster.\n* Active smoker (\\>3 cigarets/day)\n* Alcohol consumption (\\>10g/day)\n* Individual with high skin sensitivity due to skin diseases\n* Mental disorders\n* Persons who refuse to sign the information sheet and participation agreement\n* Persons under guardianship or not subject to a social security system\n* Pregnant woman, parturient, breastfeeding mother\n* Person deprived of liberty by judicial or administrative decision\n* A person who is subject to a legal protection measure that cannot be included in clinical trials.'}, 'identificationModule': {'nctId': 'NCT03992651', 'acronym': 'CTCO', 'briefTitle': 'Optical Transcutaneous Sensors of Capnia and Oxygenation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation', 'orgStudyIdInfo': {'id': 'EssaiClinique_CTCO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'One single group of healthy subjects', 'interventionNames': ['Device: Measurements of capnia and tissue oxygenation by optical transcutaneous sensors']}], 'interventions': [{'name': 'Measurements of capnia and tissue oxygenation by optical transcutaneous sensors', 'type': 'DEVICE', 'description': 'Capnia and tissue oxygenation will be measured by optical transcutaneous sensors', 'armGroupLabels': ['Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38042', 'city': 'Grenoble', 'state': 'Auvergne-Rhône-Alpes', 'country': 'France', 'facility': 'Grenoble Alpes University Hospital', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Stéphane Doutreleau, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Grenoble Alpes Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}