Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-29 @ 8:23 PM
Study NCT ID:
NCT01592435
Status:
COMPLETED
Last Update Posted:
2017-04-06
First Post:
2012-05-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013124', 'term': 'Spinal Injuries'}], 'ancestors': [{'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'susan.pate@carestream.com', 'phone': '585-627-6557', 'title': 'Susan Pate, MS, RN, RAC, Senior Manager, Clinical Affairs', 'organization': 'Carestream Health, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Predicate - Cedera AccuStitch Software', 'description': 'Cedara Accustitch is the standard of care software currently used by sites.', 'otherNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Invest. - Carestream DR LLI Software', 'description': 'Carestream DR LLI software is investigational software used for reconstruction.', 'otherNumAtRisk': 76, 'otherNumAffected': 0, 'seriousNumAtRisk': 76, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Predicate - Cedera AccuStitch Software', 'description': 'Cedera AccuStitch Software is standard of care software currently used at sites.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.01', 'spread': '0.04', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000'], 'pValueComment': 'level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '5 weeks after completion of data collection', 'description': '1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Invest. - Carestream DR LLI Software', 'description': 'Carestream DR LLI software is investigational software used for reconstruction.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.16', 'spread': '0.07', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.00', 'groupIds': ['OG000'], 'pValueComment': 'level of significance (alpha) = 0.05 All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '5 weeks after completion of data collection', 'description': '1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pred. & Invest.-All Study Participants', 'description': 'Cedera AccuStitch Software is standard of care software currently used at sites.\n\nCarestream DR LLI software is investigational software used for reconstruction.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pred. & Invest.-All Study Participants', 'description': 'Cedera AccuStitch Software is standard of care software currently used at sites.\n\nCarestream DR LLI software is investigational software used for reconstruction'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '57', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': '76 subjects participated from both sites. 76 image sets were reconstructed with Cedara Accustitch software and the same 76 image sets were reconstructed with Carestream DR LLI software.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2012-05-03', 'resultsFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2012-05-04', 'lastUpdatePostDateStruct': {'date': '2017-04-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-01-20', 'studyFirstPostDateStruct': {'date': '2012-05-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radlex Scale for Diagnostic Capability Ratings - Cedara Accustitch Software (Predicate)', 'timeFrame': '5 weeks after completion of data collection', 'description': '1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.'}, {'measure': 'Radlex Scale for Diagnostic Capability Ratings - Carestream DR LLI Software (Investigational)', 'timeFrame': '5 weeks after completion of data collection', 'description': '1-Non-diagnostic - Unacceptable for diagnostic purposes. 2-Limited - Acceptable, with some technical defect. 3-Diagnostic - Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary - Good, most adequate for diagnostic purposes.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spinal Injuries']}, 'descriptionModule': {'briefSummary': 'The study objective is to acquire composite images generated by the Carestream Long Length Imaging (LLI) software and demonstrate that the images stitched using the Carestream LLI software and the images stitched using a approved predicate device are acceptable for clinical use.', 'detailedDescription': 'The study consists of subject enrollment to collect images in a clinical setting, followed by a review of the stitched images by radiologists or qualified orthopedic surgeons to assess overall usability of the composite images.\n\nThis study includes clinical data collection of individual (raw and processed) and composite DR images from a Carestream device using alpha rotation to acquire the images. There is no subject involvement other than obtaining informed consent in order to use patient images and Case Record Forms (CRF), including supporting radiology reports. This study has no effect on clinical treatment and no foreseen risks to enrolled subjects.\n\nThe predicate software is currently in place at the sites. Carestream will harvest that data and reconstruct with investigational software offsite. A comparison reader study will be performed upon completion of data collection.\n\nPlease note this study is considered to be observational because there were no imaging of subject using investigational device. Subjects requiring standard of care diagnostic images were exposed using the commercially available Cedara system. The images captured on the Cedara system were then re-processed using the Carestream investigational software. Subjects gave informed consent for Carestream to reprocess their image data. They did not require any additional imaging using the investigational device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects requiring standard of care diagnostic images were exposed using the commercially available Cedara system. The images captured on the Cedara system were then re-processed using the Carestream investigational software. Subjects gave informed consent for Carestream to reprocess their image data. They did not require any additional imaging using the investigational device.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject has provided informed consent\n* Male or Female who require Long Length Imaging\n\nExclusion Criteria:\n\n* Not able or willing to provide Informed Consent, or consent is withdrawn\n* Not able to collect all required case information\n* Patients who are unable to stand\n* Images which are not clinically acceptable to the user\n* Images without a reference object such as a ruler in the image.'}, 'identificationModule': {'nctId': 'NCT01592435', 'acronym': 'LLI-MSE', 'briefTitle': 'Carestream Digital Radiography Long Length Imaging Software Data Collection Protocol', 'organization': {'class': 'INDUSTRY', 'fullName': 'Carestream Health, Inc.'}, 'officialTitle': 'Carestream Digital Radiography Long Length Imaging Manual Stitch Editor Software Data Collection', 'orgStudyIdInfo': {'id': '8H9323'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pred. & Invest.-All Study Participants', 'description': 'Cedera AccuStitch Software is standard of care software currently used at sites.\n\nCarestream DR LLI software is investigational software used for reconstruction.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '62781', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Memorial Medical Center', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '64507', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'facility': 'Heartland Regional Medical Center', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}], 'overallOfficials': [{'name': 'Larry Kirshner, BSRT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heartland Regional Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carestream Health, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}