Evaluation of Safety and Performance of the Orbix Breast Lift System

Breast Ptosis Clinical Trial

Official title:

Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00774059
• Other study ID #: MEC 08-1-024
• Status: Withdrawn
• Phase: N/A
• First received: October 15, 2008
• Last updated: October 11, 2017

Study information

• Verified date: October 2017
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Breast Ptosis

Intervention

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

Locations

Country	Name	City	State
Netherlands	Maastricht Univeristy Hospital	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Result after using the breast lift system,recurrence of ptosis.		one year
Secondary	complications		one year