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Recruitment Status : Withdrawn (No EC approval obtained)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

October 15, 2008
October 16, 2008
October 12, 2017
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Result after using the breast lift system,recurrence of ptosis. [ Time Frame: one year ]
Same as current
Complete list of historical versions of study NCT00774059 on Archive Site
complications [ Time Frame: one year ]
Same as current
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Evaluation of Safety and Performance of the Orbix Breast Lift System
Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System

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".

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Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Breast Ptosis
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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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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 -
Sexes Eligible for Study: Female
30 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
MEC 08-1-024
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Adi Cohen, Orbix Medical
Maastricht University Medical Center
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Principal Investigator: Marjoes MP Schuckman, MD Maastricht University Hospital
Study Director: Adi Cohen Orbix medical
Maastricht University Medical Center
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP