Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery (NCT05822115) | Clinical Trial Compass
UnknownNot Applicable
Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
France5 participantsStarted 2023-04-24
Plain-language summary
The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy.
This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.
Who can participate
Age range
18 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 :
* Women over the age of 18.
* Category 1 or 2 according to the Regnault classification.
* C cup breast size or larger.
* Areola "looks ahead" i.e. a distance between point A (at the top of the areola) at the median suprasternal point of approximately 16 cm to 24 cm.
* Ptosis (distance between the lowest part of the breast and the submammary fold) of a maximum of 7cm (measured in a seated position).
* Expected correction of half ptosis with decrease of 1 to 3 cup sizes.
* Patient has good quality thick skin.
* Social security scheme.
* Patient requesting breast reduction.
* Patient having signed the free and informed consent.
Non inclusion criteria :
* Areola "look down"; point A more than 25 cm.
* Ptosis greater than or equal to 8 cm.
* Thin skin.
* Smoker.
* Patient under effects of anti-coagulant.
* Patient participating in another clinical study.
* Protected patient: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, lactating woman.
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.