Evaluation of Safety and Performance of the Orbix Breast Lift System

Maastricht University Medical Center

Overview

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".

Study Type

INTERVENTIONAL

Purpose

PREVENTION

Masking

NONE

Conditions

Breast Ptosis

Interventions

Breast lift systemDEVICE

During a breast operation for ptosis a device is brought into the breast and attached to the ribs, to provide lifting of the breast

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 -

Locations (1)

Maastricht Univeristy Hospital

Maastricht, Netherlands

Outcomes

Primary Outcomes

Result after using the breast lift system,recurrence of ptosis.

Time frame: one year

Secondary Outcomes

complications

Time frame: one year

Data from ClinicalTrials.gov

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