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Evaluation of Safety and Performance of the Orbix Breast Lift System

Primary Purpose

Breast Ptosis

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Breast lift system
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Ptosis focused on measuring Breast ptosis, Breast lift

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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 -

Sites / Locations

  • Maastricht Univeristy Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

complications

Full Information

First Posted
October 15, 2008
Last Updated
October 11, 2017
Sponsor
Maastricht University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00774059
Brief Title
Evaluation of Safety and Performance of the Orbix Breast Lift System
Official Title
Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No EC approval obtained
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Ptosis
Keywords
Breast ptosis, Breast lift

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Breast lift system
Intervention Description
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 Measure Information:
Title
Result after using the breast lift system,recurrence of ptosis.
Time Frame
one year
Secondary Outcome Measure Information:
Title
complications
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: Pregnant or lactating women history of surgical procedures involving the ribs and rib cage Osteoporosis breast implants breast carcinoma auto-immune disease -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjoes MP Schuckman, MD
Organizational Affiliation
Maastricht University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adi Cohen
Organizational Affiliation
Orbix medical
Official's Role
Study Director
Facility Information:
Facility Name
Maastricht Univeristy Hospital
City
Maastricht
ZIP/Postal Code
6020AZ
Country
Netherlands

12. IPD Sharing Statement

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Evaluation of Safety and Performance of the Orbix Breast Lift System

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