Evaluation of Safety and Performance of the Orbix Breast Lift System

Maastricht University Medical Centre (MUMC)

Status: Withdrawn

Conditions: Breast Ptosis

Treatments: Device: Breast lift system

Study type: Interventional

Funder types: Other

Identifiers

NCT00774059

MEC 08-1-024

Details and patient eligibility

About

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".

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1.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 criteria

1. Pregnant or lactating women
2. history of surgical procedures involving the ribs and rib cage
3. Osteoporosis
4. breast implants
5. breast carcinoma
6. auto-immune disease -