Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT03109132
Status:
COMPLETED
Last Update Posted:
2017-12-08
First Post:
2017-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a double-blind, order randomized study. All cannulas will be numbered. The investigators, the outcomes assessors and the subjects will be blind to the identity of the cannulas. The order of which the subjects will assess the cannulas will be randomized.'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is randomnized crossover study. Every subject will assess all cannulas in randomized order.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-06', 'studyFirstSubmitDate': '2017-01-26', 'studyFirstSubmitQcDate': '2017-04-05', 'lastUpdatePostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comfort evaluation using self introduction questionnaire', 'timeFrame': '3 months', 'description': 'Measuring comfort on a scale of 1 -7, where 1 = not comfortable, 7 = very comfortable Data will be reported using self introduction questionnaires in different time intervals'}], 'secondaryOutcomes': [{'measure': 'Comfort evaluation using self introduction questionnaire - calculations', 'timeFrame': '3 months', 'description': 'The average comfort will be calculated for each time interval and for the all period. The values has no units, this is a subjective evaluation and not clinical value measured.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wearing Comfort']}, 'descriptionModule': {'briefSummary': 'The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the ears and on the face skin, the cannula itself (especially in the nostrils and the mouth surrounding) and the smell.', 'detailedDescription': 'This test compares 4 models for the duration of up to 3 days each and 2 models with duration of up to 24 hours. Each subject will tested the models and will provide feedback at predefined times during the test. During the test and according to initial result the team may decide to shorten the test duration.\n\nThe testing staff will include a dermatologist and a technical representative that will supervise the test in order to monitor and control the required performance of the subjects according to test protocol, and relevant outcomes. During the test the dermatologist will monitor any unexpected skin reaction or patient discomfort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers\n* Men and Women\n* Age 50-85\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Subjects with sensitivity to any of the products or the its ingredient\n* Subjects with sensitivity to preparation for testing bacterial plaque\n* Subjects who are treated with anti inflammatory antihistamine corticosteroids treatment\n* Subjects who are treated with Anti-thrombotic agents'}, 'identificationModule': {'nctId': 'NCT03109132', 'briefTitle': 'Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery', 'orgStudyIdInfo': {'id': 'MDT17070'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Model 1', 'description': 'Device - O2/CO2 Oral/Nasal cannula sample line - Oridion smart CapnoLine® H Plus with Wedge cannula', 'interventionNames': ['Device: Oridion Smart CapnoLine® H Plus with Wedge cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model 2', 'description': 'Device -O2/CO2 Oral/Nasal cannula sample line- Oridion smart CapnoLine® Plus with Non-Wedge cannula', 'interventionNames': ['Device: Oridion Smart CapnoLine® Plus with Non-Wedge cannula']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model 3', 'description': 'Device - Experimental sample line Model 3', 'interventionNames': ['Device: Experimental sample line Model 3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model 4', 'description': 'Device - Experimental sample line Model 4', 'interventionNames': ['Device: Experimental sample line Model 4']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model 5', 'description': 'Device - Experimental sample line Model 5', 'interventionNames': ['Device: Experimental sample line Model 5']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Model 6', 'description': 'Device - O2/CO2 cannula w/female luer (Westmed comfort plus #0504)', 'interventionNames': ['Device: O2/CO2 cannula w/female luer (Westmed comfort plus #0504)']}], 'interventions': [{'name': 'Oridion Smart CapnoLine® H Plus with Wedge cannula', 'type': 'DEVICE', 'otherNames': ['Usability test for arm 1'], 'description': 'The subjects will assess the comfort level of the different cannulas', 'armGroupLabels': ['Model 1']}, {'name': 'Oridion Smart CapnoLine® Plus with Non-Wedge cannula', 'type': 'DEVICE', 'otherNames': ['Usability test for arm 2'], 'description': 'The subjects will assess the comfort level of the different cannulas', 'armGroupLabels': ['Model 2']}, {'name': 'Experimental sample line Model 3', 'type': 'DEVICE', 'otherNames': ['Usability test for arm 3'], 'description': 'The subjects will assess the comfort level of the different cannulas', 'armGroupLabels': ['Model 3']}, {'name': 'Experimental sample line Model 4', 'type': 'DEVICE', 'otherNames': ['Usability test for arm 4'], 'description': 'The subjects will assess the comfort level of the different cannulas', 'armGroupLabels': ['Model 4']}, {'name': 'Experimental sample line Model 5', 'type': 'DEVICE', 'otherNames': ['Usability test for arm 5'], 'description': 'The subjects will assess the comfort level of the different cannulas', 'armGroupLabels': ['Model 5']}, {'name': 'O2/CO2 cannula w/female luer (Westmed comfort plus #0504)', 'type': 'DEVICE', 'otherNames': ['Usability test for arm 6'], 'description': 'The subjects will assess the comfort level of the different cannulas', 'armGroupLabels': ['Model 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62917', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'The Israeli Institute for skin reaserch', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Sarah Brenner, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Israeli Institute for Skin Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institute for Skin Research, Israel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}