An Early Phase 1 interventional study of Abdominal radiographs with microfabricated tags in Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation, sponsored by University of Michigan. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-29.
Sponsored by University of Michigan · Early Phase 1, Interventional, and Prevention
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.
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.
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Exclusion Criteria:
Pregnant female or if female has not had a negative pregnancy test prior to the research scans.
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Radiation: Abdominal radiographs with microfabricated tags
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.
Also known as: Abdominal CT (computerized tomography)
Validate the CAD (computer aided detection) system
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.
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Jul 2013, a primary completion of Apr 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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