NCT01570543

MRI Scanning of People With MR Safe Orthopedic Implants That Are Made of Metal

Development of MR Systems, Accessories, and Software for Imaging Subjects With Metallic Orthopedic Implants.

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to improve image quality, increase speed of scanning and to see how well certain products test by scanning people who have an orthopedic hip or knee metallic implant.

Detailed description

The technology comprising Magnetic Resonance (MR) imaging systems and accessories is under continuous development in order to improve the quality of images, speed of acquisition, and usability of MR devices applied to image subjects with metallic orthopedic implants. Collection of in vivo human data throughout the product development and maintenance lifecycle plays an important role in enabling the technology to be investigated, optimized, and validated. This is a pre-market investigation involving commercially available devices, investigational devices, and commercial devices modified with investigational components. The Study will be conducted for three years, over which time a number of endpoints will be collected for various devices under development.

Conditions

• Implants

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-04-04
• Last updated: 2013-10-01

Locations

1 site across 1 country: United States