WithdrawnNot Applicable

Evaluation of Safety and Performance of the Orbix Breast Lift System

Stopped: No EC approval obtained

Netherlands0

Plain-language 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".

Who can participate

Age range

30 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

.Female subject between 30-50 years of age 2. Subject is referred for mastopexy(breast lifting)due to one of the following reasons:

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: one year

Trial details

NCT IDNCT00774059

SponsorMaastricht University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Breast Ptosis trials