Evaluation of Safety and Performance of the Orbix Breast Lift System

October 11, 2017 updated by: Maastricht University Medical Center

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".

Study Overview

Status

Withdrawn

Conditions

Breast Ptosis

Intervention / Treatment

Device: Breast lift system

Study Type

Interventional

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Netherlands
- - Maastricht, Netherlands, 6020AZ
    - Maastricht Univeristy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Result after using the breast lift system,recurrence of ptosis. Time Frame: one year	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
complications Time Frame: one year	one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

Principal Investigator: Marjoes MP Schuckman, MD, Maastricht University Hospital
Study Director: Adi Cohen, Orbix medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria