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

NCT ID: NCT02009566

Last Updated: 2016-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Abdominal radiographs with microfabricated tags

Group Type EXPERIMENTAL

Abdominal radiographs with microfabricated tags

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Other Intervention Names

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Abdominal CT (computerized tomography)

Eligibility Criteria

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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.

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Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Aine Kelly, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aine Kelly, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Hospital

Locations

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University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00063233

Identifier Type: -

Identifier Source: org_study_id