Evaluation of Safety and Performance of the Orbix Breast Lift System
|ClinicalTrials.gov Identifier: NCT00774059|
Recruitment Status : Withdrawn (No EC approval obtained)
First Posted : October 16, 2008
Last Update Posted : October 12, 2017
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".
|Condition or disease||Intervention/treatment||Phase|
|Breast Ptosis||Device: Breast lift system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System|
- Device: Breast lift system
During a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast
- Result after using the breast lift system,recurrence of ptosis. [ Time Frame: one year ]
- complications [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774059
|Maastricht Univeristy Hospital|
|Maastricht, Netherlands, 6020AZ|
|Principal Investigator:||Marjoes MP Schuckman, MD||Maastricht University Hospital|
|Study Director:||Adi Cohen||Orbix medical|