Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT01791569
Status:
COMPLETED
Last Update Posted:
2013-12-06
First Post:
2012-11-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulse Oximetry- Evaluating Sensor Off- PCBA-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-05', 'studyFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2013-02-12', 'lastUpdatePostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Device posts Sensor Off within 1 minute after sensor is removed at least 90% of the time.', 'timeFrame': '1-2 hours per subject'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications when the sensor is removed from the finger.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, Well Perfused subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects 18 or older (inclusive).\n2. Subject is able to participate for the duration of the study\n3. Subject is willing to sign an informed consent\n\nExclusion Criteria:\n\n1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors\n2. Physiologic abnormalities that prevent proper application of a medical sensor and electrode\n3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes'}, 'identificationModule': {'nctId': 'NCT01791569', 'briefTitle': 'Pulse Oximetry- Evaluating Sensor Off- PCBA-1', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Sensor Off Studies Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1', 'orgStudyIdInfo': {'id': 'COVMOPR0303'}}, 'contactsLocationsModule': {'locations': [{'zip': '80301', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'Covidien', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}