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Evaluation of Safety and Performance of the Orbix Breast Lift System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00774059
First received: October 15, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted

October 15, 2008
October 15, 2008
January 2009
January 2010   (final data collection date for primary outcome measure)
Result after using the breast lift system,recurrence of ptosis. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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".

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
5
January 2011
January 2010   (final data collection date for primary outcome measure)

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 -
Female
30 Years to 50 Years
Yes
Contact: Adi Cohen 972-4-6818800/1 adi@haargaz.co.il
Contact: Marjoes MP Schuckman, MD 0433876543 mschuckman@hotmail.com
Netherlands
 
NCT00774059
MEC 08-1-024
Yes
Adi Cohen, Orbix Medical
Maastricht University Medical Center
Not Provided
Principal Investigator: Marjoes MP Schuckman, MD Maastricht University Hospital
Study Director: Adi Cohen Orbix medical
Maastricht University Medical Center
October 2008

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