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

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

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02009566
• Other study ID #: HUM00063233
• Status: Withdrawn
• Phase: Phase 0
• First received: November 11, 2013
• Last updated: February 26, 2016
• Start date: July 2013
• Est. completion date: August 2015

Study information

• Verified date: February 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years	Yes