USDOE Human Subjects Research Database, fiscal year 1995

Sandia National Laboratories

Project Identifier: SNL-92-02

Project Title:

3D Ultrasound Imaging for Diagnostic Imaging (formerly Non-Invasive Scanning Techniques for Prosthetic Applications)

Principle Investigator: Mr. Alan Morimoto

Project started in: 1992

Fiscal Year 1995 Funding for Research on Human Subjects:

Project Funding Information:
Project received funding in Fiscal Year 1995.
Project did not use human subjects in Fiscal Year 1995.

Explanation:

Human subjects will not be needed until late 1995 (FY 1996), but this was not realized until late in this FY.

Funding Sources:

Non-DOE Federal: Advanced Research Projects Agency (ARPA), Department of Defense

Amount: $0

Information on Use of Human Subjects:

Project does not involve use of multiple protocols/subprojects.

IRB Review:
Type of Review: Expedited
Most Recent Approval: February 14, 1995

Number of Human Subjects in the Last Reporting Period for this Project: 25
(Reporting periods vary.)

Type of Human Subjects Involvement:

Instrument/Device/Product Testing or Man-Machine Studies:

Use of human subjects to develop/test instruments, materials, devices, or objects.

(a. Objectives, b. Methodology, c. Ionizing Radiation, Radioactive Substances, or Chemical Substances to which human subjects are exposed, d. Involvement of Human Subjects [d.1. procedures used, d.2. risks if any])

a. Development of a new ultrasound based scanner.

b. Scanner is based on approved commercially available ultrasound machine and will be used to define skin and bone surface geometry of human limbs (legs and arms). Scanner can be used for study of amputee limbs, limbs that have suffered injury or disease and are completely encased in skin or sterile sheath, and normal limbs. Information gathered on the limb will be used for fabrication of prostheses; in the case of the amputee, for refinement of the scanning platform for diagnostic image generation; and for studies of comparative anatomy. Uniqueness is use of ultrasound for high resolution three-dimensional images similar in format to x-ray computed tomography without suffering hazards of ionizing radiation.

d. Individual places leg (or arm) into water bath, used as transmission medium for ultrasound. Tank that surrounds water houses the ultrasound probe which takes images of the leg as the tub rotates around the leg. Procedure lasts approximately 20 seconds. Energy levels and duration of exposure are below Food and Drug Administration (FDA) limits and do not pose any known health risks.