Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT05348512
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laboratory Study for the Acquisition of Spectral and Photoplethysmographic Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 65}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-12', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-20', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RGB video data', 'timeFrame': '16 minutes', 'description': 'true color video data (10 bit per channel \\[red, green, blue\\]) from tongues and fingers'}, {'measure': 'hyperspectral data', 'timeFrame': '16 minutes', 'description': 'false color parameter images, representing the oxygenation in %; the perfusion; the hemoglobin, water, and fat content of tissue in arbitrary units betwenn 0 and 100 from tongues and fingers (imaged areas have to correspond to RGB video data)'}, {'measure': 'multispectral video data', 'timeFrame': '16 minutes', 'description': 'true color video data (10 bit per channel \\[red, green, blue\\]) from tongues and fingers (imaged areas have to correspond to RGB video data)'}, {'measure': 'plethysmographic wave', 'timeFrame': '5 minutes', 'description': 'numerical value in arbitrary values representing the amount of transmitted/reflected light over time through fingers or earlobes or from the forehead'}, {'measure': 'pulse', 'timeFrame': '5 minutes', 'description': 'frequency in bpm (beats per minute) or Hz (Hertz)'}, {'measure': 'pulsation index', 'timeFrame': '5 minutes', 'description': 'ratio between pulsating and non-pulsating tissue components in %'}, {'measure': 'SpO2', 'timeFrame': '5 minutes', 'description': 'oxygenation of arterial blood in %, measured with a pulse oximeter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'Laboratory study on healthy volunteers to acquire spectral video data from the tongue and fingers as well as photoplethysmographic data from the forehead, fingers, and earlobes to evaluate and optimize algorithms for imaging photoplethysmography (iPPG) and multispectral imaging (MSI)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'healthy volunteers \\>= 18 years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers \\>= 18 years old\n\nExclusion Criteria:\n\n* pregnant and nursing women\n* persons unable to consent\n* persons with tattoos or diseases on the tongue, finger, ear, or forehead\n* narcoleptics\n* epileptics\n* persons with arterial hypertension, peripheral arterial disease, anemia, Raynaud syndrome, autoimmune vasculitides, Takayasu arteritis, venous insuffiencies, microangiopathy, diabetic vasculopathy, scleroderma'}, 'identificationModule': {'nctId': 'NCT05348512', 'acronym': 'LabStud_MSI', 'briefTitle': 'Laboratory Study for the Acquisition of Spectral and Photoplethysmographic Data', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Laborstudie Zur Aufnahme Spektraler Und Photoplethysmographischer Daten', 'orgStudyIdInfo': {'id': 'LabStud_MSI/iPPG'}}, 'armsInterventionsModule': {'interventions': [{'name': 'spectral imaging', 'type': 'OTHER', 'description': 'non-contact, non-invasive hyperspectral and multispectral imaging without a diagnostic test'}, {'name': 'photoplethysmography', 'type': 'OTHER', 'description': 'non-invasive pulse oximetry without a diagnostic test'}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ines Gockel', 'role': 'CONTACT', 'email': 'chi2@medizin.uni-leipzig.de', 'phone': '+49 341 - 9717200'}], 'facility': 'Department of Visceral, Transplantation, Vascular and Thoracic Surgery', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'centralContacts': [{'name': 'Ines Gockel, Prof. Dr.', 'role': 'CONTACT', 'email': 'chi2@medizin.uni-leipzig.de', 'phone': '+49 341 97', 'phoneExt': '17200'}], 'overallOfficials': [{'name': 'Ines Gockel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual data will not be shared. However, results are planned to be published in a scientific journal in a completely anonymized manner.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Univ.-Prof. Dr. med., MBA', 'investigatorFullName': 'Ines Gockel', 'investigatorAffiliation': 'University of Leipzig'}}}}