Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT03563105
Status:
UNKNOWN
Last Update Posted:
2018-06-20
First Post:
2018-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol
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': 'Vascular Occlusion Test'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-18', 'studyFirstSubmitDate': '2018-06-08', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant decrease in StO2 during occlusion', 'timeFrame': 'immediate', 'description': 'significant decrease in StO2 during occlusion'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['tissue oxygen saturation'], 'conditions': ['Circulatory; Change']}, 'descriptionModule': {'briefSummary': "The objective of this study is to evaluate the performance of Modulated Imaging Inc.'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system to measure potential circulatory compromise.", 'detailedDescription': 'The objective of this study is to demonstrate the performance of Modulated Imaging Inc.\'s (MI) next generation Spatial Frequency Domain Imaging (SFDI) system, "The Ox-Imager Mini". Potential circulatory compromise will be imaged in healthy volunteers using both the subject and predicate devices (Ox-Imager CS) in a Vascular Occlusion Test (VOT) model. The VOT model is an established paradigm to introduce transient ischemia in skin and the the subjects will be imaged during this time. The primary endpoint will be to measure significant decrease in tissue oxygen saturation after occlusion for both predicate and subject devices.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years of age\n\nExclusion Criteria:\n\n* History of congestive heart failure\n* Patients with existing wound or ulcer.\n* Rheumatoid arthritis\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT03563105', 'briefTitle': 'Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Modulated Imaging Inc.'}, 'officialTitle': 'Assessment of Circulatory Compromise With Ox-Imager Using a Vascular Occlusion Test Protocol', 'orgStudyIdInfo': {'id': '900-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Desaturation', 'description': 'Vascular Occlusion Test', 'interventionNames': ['Device: The Ox-Imager Mini (Desaturation)']}], 'interventions': [{'name': 'The Ox-Imager Mini (Desaturation)', 'type': 'DEVICE', 'description': 'Vascular Occlusion Test', 'armGroupLabels': ['Desaturation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92705', 'city': 'Santa Ana', 'state': 'California', 'country': 'United States', 'facility': 'Orange County Wound and Hyperbaric', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}], 'overallOfficials': [{'name': 'Amaan Mazhar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Modulated Imaging Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Modulated Imaging Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}