Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:15 PM
Study NCT ID:
NCT05440435
Status:
UNKNOWN
Last Update Posted:
2022-09-19
First Post:
2022-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011856', 'term': 'Radiographic Image Enhancement'}], 'ancestors': [{'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011859', 'term': 'Radiography'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2022-06-24', 'studyFirstSubmitQcDate': '2022-06-28', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The image quality rating scale score.', 'timeFrame': 'Immediately after inclusion in the study.', 'description': 'There are 24 entries in the image quality rating scale with a total score of 100 points. According to the score, there are 4 grades (A. ≥90; B. 80-89; C. 70-79; D. \\<70), among which D is unqualified.'}, {'measure': 'Difference of fracture detection rate (sensitivity and specificity) between artificial intelligence and expert diagnosis.', 'timeFrame': 'Immediately after the diagnosis is completed.', 'description': 'Sensitivity is the percentage of individuals with bone injury who diagnosed by artificial intelligence or experts. Specificity is the percentage of those without bone injury who have normal diagnosis results.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial intelligence', 'Digital radiography'], 'conditions': ['Bone Injury', 'Artificial Intelligence']}, 'descriptionModule': {'briefSummary': 'In the high cold environment, mobile digital radiography (DR) is used to collect the imaging of bone injury patients, and the artificial intelligence diagnosis module is used to diagnose the injury. The quality of images obtained by mobile or conventional DR and the consistency between artificial intelligence and pure artificial diagnosis will be analyzed respectively. Finally, the application value of mobile DR loaded with artificial intelligence diagnosis function in high cold environment is determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The population in the surrounding areas of the five centers set up in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with new bone injury\n\nExclusion Criteria:\n\n* Life threatening.\n* Head injury and fracture.\n* There are congenital malformations in the bone injury site.'}, 'identificationModule': {'nctId': 'NCT05440435', 'briefTitle': 'Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Chinese Armed Police Forces'}, 'officialTitle': 'Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment', 'orgStudyIdInfo': {'id': 'DR001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Center A', 'description': 'Study center A that observe cohort populations (sample size=400).', 'interventionNames': ['Diagnostic Test: digital radiography (DR)']}, {'label': 'Center B', 'description': 'Study center B that observe cohort populations (sample size=400).', 'interventionNames': ['Diagnostic Test: digital radiography (DR)']}, {'label': 'Center C', 'description': 'Study center C that observe cohort populations (sample size=400).', 'interventionNames': ['Diagnostic Test: digital radiography (DR)']}, {'label': 'Center D', 'description': 'Study center D that observe cohort populations (sample size=400).', 'interventionNames': ['Diagnostic Test: digital radiography (DR)']}, {'label': 'Center E', 'description': 'Study center E that observe cohort populations (sample size=400).', 'interventionNames': ['Diagnostic Test: digital radiography (DR)']}], 'interventions': [{'name': 'digital radiography (DR)', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with bone injury received routine and mobile DR sequential examination.', 'armGroupLabels': ['Center A', 'Center B', 'Center C', 'Center D', 'Center E']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rongrong Hua, Dr.', 'role': 'CONTACT', 'email': 'huarongrong1011@163.com', 'phone': '+8615810159356'}], 'facility': 'Center A', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Neimeng', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xucheng He', 'role': 'CONTACT'}], 'facility': 'Xucheng He', 'geoPoint': {'lat': 28.53675, 'lon': 119.33442}}, {'city': 'Xinjiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xucheng He', 'role': 'CONTACT'}], 'facility': 'Center C', 'geoPoint': {'lat': 30.46809, 'lon': 120.44325}}, {'city': 'Xizang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xucheng He', 'role': 'CONTACT'}], 'facility': 'Center', 'geoPoint': {'lat': 33.87378, 'lon': 103.95161}}], 'centralContacts': [{'name': 'Rongrong Hua, Doctor', 'role': 'CONTACT', 'email': 'huarongrong1011@163.com', 'phone': '0086-15810159356'}], 'overallOfficials': [{'name': 'Guisheng Wang, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Third center of PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rongrong Hua', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Rongrong Hua', 'investigatorAffiliation': 'General Hospital of Chinese Armed Police Forces'}}}}