Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00233922
Status:
COMPLETED
Last Update Posted:
2008-05-13
First Post:
2005-10-05
Brief Title:
Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
Reconstruction of the Orbit With a Bioresorbable Polycaprolactone Implant
Status:
COMPLETED
Status Verified Date:
2008-05
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:
Patients with orbital injuries are entered into the trial Age 20 - 70 After obtaining appropriate consent they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh established practice or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone Patients are followuped at 1 week 1 month 3 months 6 months 12 months CT scan of the orbits are performed preop 6 months 12 months End point is the 12 month follow-up appointment Visual acuity range of motion enophthalmos diplopia are assessed in follow-up
Detailed Description:
Patients with orbital injuries are entered into the trial Age 20 - 70 After obtaining appropriate consent they are entered into either a control arm where reconstruction of the orbit is done with a titanium mesh established practice or the experimental arm where reconstruction is by a bioresorbable implant made of polycaprolactone Patients are followuped at 1 week 1 month 3 months 6 months 12 months CT scan of the orbits are performed preop 6 months 12 months End point is the 12 month follow-up appointment Visual acuity range of motion enophthalmos diplopia are assessed in follow-up
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NHGRPR04024 | None | None | None |