Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT05022602
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2021-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sschaeffer@senomedical.com', 'phone': '6106983259', 'title': 'Shaan Schaeffer', 'organization': 'Seno Medical, Inc.'}, 'certainAgreement': {'otherDetails': "INSTITUTION/INVESTIGATOR will provide such proposed publications/presentations, to SPONSOR for review, at least thirty (30) days prior to submission for publication or of public disclosure. SPONSOR will complete its review within thirty (30) days of receipt of the submitted publications/presentations. The INSTITUTION shall consider SPONSOR's suggestions and comments to the manuscript to be published.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were recorded from the time the patient entered the Imagio imaging room until they departed from the facility the same day. There were no follow-up exams for this study (up to 3 hours).', 'eventGroups': [{'id': 'EG000', 'title': 'Imagio', 'description': 'Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes\n\nImagio: Imagio - both ultrasound probe and Duplex OA probe', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 1, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Medical Device Site Warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '2.6'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Imagio Image Sets Collected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imagio', 'description': 'Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes\n\nImagio: Imagio - both ultrasound probe and Duplex OA probe'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Completed Pathology Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Imagio', 'description': 'Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes\n\nImagio: Imagio - both ultrasound probe and Duplex OA probe'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': "Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Imagio', 'description': 'Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes\n\nImagio: Imagio - both ultrasound probe and Duplex OA probe'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Imagio', 'description': 'Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes\n\nImagio: Imagio - both ultrasound probe and Duplex OA probe'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.3', 'spread': '15.41', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-10', 'size': 2264458, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-06T14:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2021-08-20', 'resultsFirstSubmitDate': '2023-01-19', 'studyFirstSubmitQcDate': '2021-08-20', 'lastUpdatePostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-28', 'studyFirstPostDateStruct': {'date': '2021-08-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Imagio Image Sets Collected', 'timeFrame': 'Baseline', 'description': 'Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled.'}, {'measure': 'Number of Subjects With Completed Pathology Results', 'timeFrame': 'Baseline', 'description': "Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Breast Cancer Stage']}, 'descriptionModule': {'briefSummary': 'This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).', 'detailedDescription': '1. Obtain ultrasound only probe images and duplex probe OA/US (both gray scale and OA) probe images. This includes doppler and elastography imaging with the gray scale only ultrasound probe and ultrasound mode of the duplex OA/US probe.\n2. Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Has a signed and dated informed consent, prior to initiation of any study-related activities.\n2. Is at least 18 years of age.\n3. Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.\n4. Is willing and able to comply with protocol-required scans\n\nExclusion Criteria:\n\n1. Is pregnant or lactating.\n2. Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) which could interfere with the intended field of view.\n3. Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as some sulfur containing drugs, ampicillin, tetracycline.\n4. Is currently undergoing phototherapy.\n5. Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.\n6. Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.\n7. Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.\n8. Currently has mastitis.\n9. Prisoners'}, 'identificationModule': {'nctId': 'NCT05022602', 'briefTitle': 'Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Seno Medical Instruments Inc.'}, 'officialTitle': 'Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System', 'orgStudyIdInfo': {'id': 'Gen 2 - 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imagio', 'description': 'Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes', 'interventionNames': ['Device: Imagio']}], 'interventions': [{'name': 'Imagio', 'type': 'DEVICE', 'description': 'Imagio - both ultrasound probe and Duplex OA probe', 'armGroupLabels': ['Imagio']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Health', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Pam Otto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHSC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seno Medical Instruments Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'American College of Radiology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}