Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06238076
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2024-01-11
Brief Title:
Evaluation of an Universal Surgical Device for Mandibular Reconstruction
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Universal Surgical Device for Mandibular Reconstruction Using Fibula Free Flap Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
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:
FIBUMAND
Brief Summary:
Fibula free flap is the gold standard for mandibular reconstruction The shape of the fibula requires osteotomy that can be performed with a custom surgical guide The use of surgical guide shorten surgical time enhances the precision of the surgeon and reduces morbidity
Since 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide
The aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide
Since 2008 custom surgical guide have been used in the hospital department and the clinical team have noticed a number of elements which leads investigator to think that it would be possible to perform this kind of procedure using an universal guide
The aim of this study is to assess the possibility to perform mandibular fibula free flap reconstruction with an universal guide
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None