Evaluation of Safety and Performance of the Orbix Breast Lift System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00774059
Recruitment Status : Withdrawn (No EC approval obtained)
First Posted : October 16, 2008
Last Update Posted : October 12, 2017
Information provided by:
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".

Condition or disease Intervention/treatment Phase
Breast Ptosis Device: Breast lift system Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System

Intervention Details:
  • 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

Primary Outcome Measures :
  1. Result after using the breast lift system,recurrence of ptosis. [ Time Frame: one year ]

Secondary Outcome Measures :
  1. complications [ Time Frame: one year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00774059

Maastricht Univeristy Hospital
Maastricht, Netherlands, 6020AZ
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: Marjoes MP Schuckman, MD Maastricht University Hospital
Study Director: Adi Cohen Orbix medical

Responsible Party: Adi Cohen, Orbix Medical Identifier: NCT00774059     History of Changes
Other Study ID Numbers: MEC 08-1-024
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017

Keywords provided by Maastricht University Medical Center:
Breast ptosis, Breast lift