Ignite Creation Date:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2026-03-14 @ 5:53 AM
Study NCT ID:
NCT06586918
Status:
COMPLETED
Last Update Posted:
2024-10-26
First Post:
2024-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perfusion Index Parameter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-23', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perfusion Index (PI) correlation to doppler measurement', 'timeFrame': '1 hour', 'description': 'To confirm correlation of Perfusion Index measured by the investigational pulse oximeter PCBA and Market Released sensors to the laser doppler measure of skin perfusion (LDSP) as determined by an overall instantaneous (lag(0)) Spearman rank correlation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Perfusion; Complications']}, 'descriptionModule': {'briefSummary': 'To evaluate the association between the Perfusion index parameter and an independent measure of perfusion.', 'detailedDescription': 'Perfusion index parameters measured with an Investigational Pulse Oximetry PCBA, paired with Market Released sensors, will be compared to perfusion levels measured by a FDA-cleared device equipped with a laser Doppler technology-based device for blood perfusion measurements. Continuous Perfusion index measurements will be taken during the test sequence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Male or Female volunteers age ≥18 years, weighing greater than 40kgs.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects ≥18 years of age\n2. Subject is able to participate for the duration of the study\n3. Subject is willing to sign an informed consent\n4. Subject weighs \\>40kg\n\nExclusion Criteria:\n\n1. Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect the ability to test sensors\n2. Physiologic abnormalities that prevent proper application of pulse oximetry sensor\n3. Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes.\n4. Raynaud Syndrome\n5. Repeated systolic blood pressure \\> 140mmHg -'}, 'identificationModule': {'nctId': 'NCT06586918', 'briefTitle': 'Perfusion Index Parameter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Verification of a Perfusion Index Parameter in Adult Volunteers', 'orgStudyIdInfo': {'id': 'MDT23025OM2VLP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Medtronic Clinical Physiology Lab', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}], 'overallOfficials': [{'name': 'Randall M Clark, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medtronic Clinical Physiology Lab'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}