Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT02009566
Status:
WITHDRAWN
Last Update Posted:
2016-02-29
First Post:
2013-11-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Initial PI Dr. Marentis left the University of Michigan hospital', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-26', 'studyFirstSubmitDate': '2013-11-11', 'studyFirstSubmitQcDate': '2013-12-08', 'lastUpdatePostDateStruct': {'date': '2016-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validate the CAD (computer aided detection) system', 'timeFrame': '3 years', 'description': 'X-rays of the microfabricated tag will be taken. These x-rays will be reviewed and the individual tags identified manually and a control file created. The images will then be processed by the CAD (computer aided detection)system and the output will be compared to the control file.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation']}, 'descriptionModule': {'briefSummary': "Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray.", 'detailedDescription': "Surgical sponges can be accidentally left inside patient's bodies. We are working on special tags (called microfabricated tags) that surgeons can put on their sponges. Then, if the surgeons forget to remove a sponge from a patient, they'll be able to detect these special tags in an x-ray. We wish to take x-rays of healthy people's abdomens with microfabricated tags lying on them. The x-rays will help us improve our system for detecting sponges left inside people's bodies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy men and women\n2. Ages 18 or older -\n\nExclusion Criteria:\n\n1. Under 18 years of age\n2. Pregnant female or if female has not had a negative pregnancy test prior to the research scans.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT02009566', 'briefTitle': 'Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges', 'orgStudyIdInfo': {'id': 'HUM00063233'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abdominal radiographs with microfabricated tags', 'interventionNames': ['Radiation: Abdominal radiographs with microfabricated tags']}], 'interventions': [{'name': 'Abdominal radiographs with microfabricated tags', 'type': 'RADIATION', 'otherNames': ['Abdominal CT (computerized tomography)'], 'description': 'Subjects will have 2 x-rays of their lower thorax/ abdomen taken. For each x-ray, a microfabricated tag or no tag will be placed in a different position. The x-rays will take approximately 15 minutes to complete.', 'armGroupLabels': ['Abdominal radiographs with microfabricated tags']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Aine Kelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aine Kelly, MD', 'investigatorAffiliation': 'University of Michigan'}}}}