Skip to content

Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges

Healthy Volunteer Visibility Study of Micromachined Tags for the Detection of Surgical Sponges

Status
Withdrawn
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02009566
Enrollment
0
Registered
2013-12-12
Start date
2013-07-31
Completion date
2015-08-31
Last updated
2016-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation

Brief summary

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.

Detailed description

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.

Interventions

RADIATIONAbdominal 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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Healthy men and women 2. Ages 18 or older -

Exclusion criteria

1. Under 18 years of age 2. Pregnant female or if female has not had a negative pregnancy test prior to the research scans. \-

Design outcomes

Primary

MeasureTime frameDescription
Validate the CAD (computer aided detection) system3 yearsX-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026