Ignite Creation Date:
2024-05-05 @ 11:46 PM
Last Modification Date:
2024-10-26 @ 10:39 AM
Study NCT ID:
NCT01416233
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2011-05-30
Brief Title:
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Sponsor:
Fox Donald Munro MD PC
Organization:
Fox Donald Munro MD PC
Study Overview
Official Title:
Autologous Fat Augmentation of Orbital Volume Using a Closed Cannula Technique
Status:
COMPLETED
Status Verified Date:
2018-08
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:
After enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell Current techniques for correction require open surgery to place a sheetblock of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction Alternatively hyaluronic acid-base fillers Restylane Radiesse have been injected but these have proved to be temporary The current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat
Detailed Description:
To date 5 subjects have completed fat injections and 45 have acquired complete sets of 3 MRIs each Data analysis has begun The study has been extended to include 5 more subjects total 10 to increase the number of data for analysis
To date the protocol has been expanded to include 10 subjects of which 610 have completed fat injections The study period has been extended to include MRIs at 2 and 5 years after injection
To date the protocol has been expanded to include 10 subjects of which 610 have completed fat injections The study period has been extended to include MRIs at 2 and 5 years after injection
Study Oversight
Has Oversight DMC:
None
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?:
None