Evaluation of Safety and Performance of the Orbix Breast Lift System

Not Applicable

Withdrawn

• Conditions: Breast Ptosis

• Registration Number: NCT00774059
• Lead Sponsor: Maastricht University Medical Center

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".

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Result after using the breast lift system,recurrence of ptosis.	one year

Secondary Outcome Measures

Name	Time	Method
complications	one year

Trial Locations

Locations (1)

Maastricht Univeristy Hospital; 🇳🇱 Maastricht, Netherlands