Evaluation of Safety and Performance of the Orbix Breast Lift System
Recruitment status was: Not yet recruiting
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".
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System|
- Result after using the breast lift system,recurrence of ptosis. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Device: Breast lift system
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774059
|Maastricht Univeristy Hospital|
|Maastricht, Netherlands, 6020AZ|
|Principal Investigator:||Marjoes MP Schuckman, MD||Maastricht University Hospital|
|Study Director:||Adi Cohen||Orbix medical|