Ignite Creation Date:
2025-12-24 @ 12:23 PM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT02948361
Status:
UNKNOWN
Last Update Posted:
2022-04-22
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS
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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-10-26', 'lastUpdatePostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QT Ultrasound scans', 'timeFrame': 'Scan session is 2 to 3 hours', 'description': 'The capabilities of the QT Ultrasound scanner will be measured by the review of the QT Ultrasound scans at the conclusion of each QT Ultrasound scan session'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Volunteer Subjects']}, 'descriptionModule': {'briefSummary': 'Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per ACR recommendations.\n\nIf available, subjects may provide copies of their breast imaging exams and related reports.\n\nDemographics and medical history will be collected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years old\n* Willing and able to provide written, signed informed consent\n* Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n* Inability to tolerate the scan\n* Present infection risk\n* Allergies to device materials\n* Inability to successfully "fit" breast into the investigational device\n* Currently pregnant as reported by the subject\n* Body weight greater than 400 lbs. (180 kg)\n* Any other conditions that the Investigator determines to interfere with the conduct of the study or evaluation of results'}, 'identificationModule': {'nctId': 'NCT02948361', 'acronym': 'PROGRESS', 'briefTitle': 'Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS', 'organization': {'class': 'INDUSTRY', 'fullName': 'QT Ultrasound LLC'}, 'officialTitle': 'Clinical PRoduct DevelOpment StudyinG the QT Ultrasound® BReast ScannEr With Volunteer SubjectS', 'orgStudyIdInfo': {'id': 'BR004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QT Ultrasound breast scan', 'interventionNames': ['Other: QT Ultrasound Breast Scan']}], 'interventions': [{'name': 'QT Ultrasound Breast Scan', 'type': 'OTHER', 'description': 'Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per American College of Radiology (ACR) recommendations.', 'armGroupLabels': ['QT Ultrasound breast scan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94949', 'city': 'Novato', 'state': 'California', 'country': 'United States', 'facility': 'Marin Breast Health Trial Center', 'geoPoint': {'lat': 38.10742, 'lon': -122.5697}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QT Ultrasound LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}