Status:
WITHDRAWN
Evaluation of Safety and Performance of the Orbix Breast Lift System
Lead Sponsor:
Maastricht University Medical Center
Conditions:
Breast Ptosis
Eligibility:
FEMALE
30-50 years
Phase:
NA
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 mini...
Eligibility Criteria
Inclusion
- Female subject between 30-50 years of age 2. Subject is referred for mastopexy(breast lifting)due to one of the following reasons:
- Breast ptosis grade I or II (minimal invasive)
- Breast ptosis grade I to IV (open procedure)
- pseudoptosis following breast reduction surgery 3. subject willing to participate as evidenced by signing the written informed consent 4. Minimal invasive: breast cup size \<C
Exclusion
- Pregnant or lactating women
- history of surgical procedures involving the ribs and rib cage
- Osteoporosis
- breast implants
- breast carcinoma
- auto-immune disease -
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00774059
Last Update
October 12 2017
Active Locations (1)
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1
Maastricht Univeristy Hospital
Maastricht, Netherlands, 6020AZ