Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-04-13 @ 9:19 AM
Study NCT ID:
NCT02831556
Status:
COMPLETED
Last Update Posted:
2024-05-21
First Post:
2016-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Point of Care 3D Ultrasound for Various Applications: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D042882', 'term': 'Gallstones'}, {'id': 'D011271', 'term': 'Pregnancy, Ectopic'}, {'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D007669', 'term': 'Kidney Calculi'}, {'id': 'D004238', 'term': 'Diverticulitis'}, {'id': 'D000007', 'term': 'Abdominal Injuries'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D011127', 'term': 'Polyps'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D002769', 'term': 'Cholelithiasis'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D041761', 'term': 'Cholecystolithiasis'}, {'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D002137', 'term': 'Calculi'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D014545', 'term': 'Urinary Calculi'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000076385', 'term': 'Diverticular Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2016-07-11', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Experimental ultrasound diagnosis agreement with final reference standard diagnosis', 'timeFrame': 'Comparison of experimental ultrasound diagnosis with final reference diagnosis will occur at approximately 4 weeks (average) after date of experimental ultrasound exam, to allow clinical follow-up to occur.'}], 'secondaryOutcomes': [{'measure': 'Duration of experimental ultrasound exam', 'timeFrame': 'The duration of the experimental ultrasound exam in seconds will be digitally recorded at the time of its performance. We anticipate the ultrasound duration to be less than 600 seconds'}, {'measure': 'Experimental ultrasound image quality.', 'timeFrame': "4 weeks (average). Images will be reviewed after the completion of each subject's acute care. Image review will usually occur within 4 weeks."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ultrasound', 'Abdomen', 'Pelvis', '3D'], 'conditions': ['Appendicitis', 'Evidence of Cholecystectomy', 'Gallstones', 'Pregnancy, Ectopic', 'Aortic Aneurysm', 'Kidney Stones', 'Intrauterine Pregnancy', 'Diverticulitis', 'Abdominal Injuries', 'Tumors', 'Pancreatitis', 'Digestive System Diseases', 'Gastrointestinal Diseases', 'Intraabdominal Infections', 'Intestinal Diseases', 'Pregnancy', 'Vascular Disease', 'Uterine Fibroids', 'Ovarian Cysts', 'Uterine Abnominalies', 'Bladder Abnominalies', 'Testicular Abnominalies', 'Polyps']}, 'descriptionModule': {'briefSummary': "Summary\n\n1. Purpose and Objective: The purpose of this study is to test the feasibility of rapid acquisition of point of care 3D ultrasound in obtaining abdominal and/or pelvic images. The study will use a newly developed acquisition method and post-processing technique to create three dimensional image models of the abdomen and/or pelvis.\n2. Study activities and population group. The study population will be a convenience sample of patients of any age presenting to the Emergency Department with complaints necessitating a clinical abdominal and/or pelvic imaging. The study intervention includes acquisition of research ultrasound images, which will not be used for clinical care, and comparison of these images with clinically obtained images. Other clinical data such as surgical and pathology reports will also be reviewed. 3.Data analysis and risk/safety issues. This is a pilot study intended to determine feasibility and to refine image reconstruction algorithms. Research images will be compared to clinical images. Comparison of research images with final diagnosis will also occur. The research intervention, an ultrasound exam, has no known safety risks. The only risk to subjects is loss of confidentiality.\n\nThis study is observational, not interventional, because the experimental ultrasound will be performed in all subjects and will not be used in the clinical care of patients (consequently, will not have the opportunity to affect clinical outcomes). Experimental images will be reviewed after completion of clinical care and will not be provided to the clinicians caring for the subjects. The investigators are not measuring the effect of the ultrasound examination on the subjects' outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of any age that present to the Emergency Department with chief complaints suspected to be related to an abdominal or pelvic pathology for which clinical imaging is ordered.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Potential subjects must present to the emergency department for evaluation of complaints suspected to be related to an abdominal or pelvic pathology. The clinical diagnostic plan before subject enrollment may include abdominal or pelvic ultrasound, CT scan and/or MRI.\n\nOR\n\n* Non-patient volunteer\n\nExclusion Criteria:\n\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT02831556', 'briefTitle': 'Point of Care 3D Ultrasound for Various Applications: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'A Pilot Study to Test Rapid Acquisition of Point of Care Ultrasound for Various Applications', 'orgStudyIdInfo': {'id': 'Pro00071789'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Emergency Department Subjects', 'description': 'Subjects that present to the Emergency Department with complaints necessitating abdominal or pelvic imaging.'}, {'label': 'Non-patient volunteers', 'description': 'Duke employees that will voluntarily have an abdominal or pelvic ultrasound for with the sole purpose being for the study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Joshua Broder, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Wallace H. Coulter Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}