Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-29 @ 3:36 AM
Study NCT ID:
NCT00774059
Status:
WITHDRAWN
Last Update Posted:
2017-10-12
First Post:
2008-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Performance of the Orbix Breast Lift System
Sponsor:
Maastricht University Medical Center
Organization:
Study Overview
Official Title:
Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System
Status:
WITHDRAWN
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No EC approval obtained
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is using a new breast lift system to complement a breast-lift operation.
In general there will be recurrence of breast-ptosis after a correcting operation.
With this device we want to minimize this recurrence and provide an "internal bra".
In general there will be recurrence of breast-ptosis after a correcting operation.
With this device we want to minimize this recurrence and provide an "internal bra".
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: