NCT00774059

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".

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 16, 2008

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

First QC Date

October 15, 2008

Last Update Submit

October 11, 2017

Conditions

Breast Ptosis

Keywords

Breast ptosis, Breast lift

Outcome Measures

Primary Outcomes (1)

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

    one year

Secondary Outcomes (1)

  • complications

    one year

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 Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant or lactating women
  • history of surgical procedures involving the ribs and rib cage
  • Osteoporosis
  • breast implants
  • breast carcinoma
  • auto-immune disease -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht Univeristy Hospital

Maastricht, 6020AZ, Netherlands

Location

Study Officials

  • Marjoes MP Schuckman, MD

    Maastricht University Hospital

    PRINCIPAL INVESTIGATOR

  • Adi Cohen

    Orbix medical

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 16, 2008

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

NL(1)