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
  Purpose

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 Intervention Phase
Breast Ptosis
Device: Breast lift system
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Result after using the breast lift system,recurrence of ptosis. [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00774059

Contacts
Contact: Adi Cohen 972-4-6818800/1 adi@haargaz.co.il
Contact: Marjoes MP Schuckman, MD 0433876543 mschuckman@hotmail.com

Locations
Netherlands
Maastricht Univeristy Hospital Not yet recruiting
Maastricht, Netherlands, 6020AZ
Principal Investigator: Rene RJ v. d. Hulst, PhD         
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Marjoes MP Schuckman, MD Maastricht University Hospital
Study Director: Adi Cohen Orbix medical
  More Information

No publications provided

Responsible Party: Adi Cohen, Orbix Medical
ClinicalTrials.gov Identifier: NCT00774059     History of Changes
Other Study ID Numbers: MEC 08-1-024
Study First Received: October 15, 2008
Last Updated: October 15, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on October 21, 2014