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

Early Phase 1

Withdrawn

• Conditions: Injury Due to Foreign Object Accidentally Left in Body During Surgical Operation
• Interventions: Radiation: Abdominal radiographs with microfabricated tags

• Registration Number: NCT02009566
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-12-08
• Study First Posted: 2013-12-12
• Primary Completion: 2015-04
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-26
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abdominal radiographs with microfabricated tags	Abdominal radiographs with microfabricated tags	-

Primary Outcome Measures

Name	Time	Method
Validate the CAD (computer aided detection) system	3 years	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States