Viewing Study NCT01245504


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Study NCT ID: NCT01245504
Status: COMPLETED
Last Update Posted: 2014-04-25
First Post: 2010-11-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Assessment of Socket Shapes Made by Central Fabrication Facilities
Sponsor: University of Washington
Organization:

Study Overview

Official Title: Clinical Evaluation of an Algorithm to Assess Sockets Made by Central Fabrication Facilities
Status: COMPLETED
Status Verified Date: 2014-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Quality and accuracy of prosthetic sockets manufactured by central fabrication facilities may be lacking. Poor quality manufacturing can be detrimental to socket fit in amputees and may require more work by prosthetists to redesign the socket. The aim of this research is to assess the accuracy of prosthetic sockets manufactured by commercial companies. Determination of how and where manufacturing errors occur will contribute to better quality of socket fit for the amputee patient and improve the efficiency of prosthetists who fit the manufactured products to their patients.

Computer manufactured sockets are made for subjects, then their fits assessed by research practitioners.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: