UnknownNot Applicable

Reduction of Breast Enlargement Using the Da Vinci Xi Robot

France5 participantsStarted 2020-11-01

Plain-language summary

Breast enlargement reductions are frequent interventions. One of the main issue associated with this surgery remains the ransom scar, wide at the periareolar level, vertical at the subareolar level and in the submammary groove. The expected result is to achieve a reduction in breast enlargement with no visible scar using Da Da Vinci Xi robot.

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 classification of Regnault * Breast size cup c or more * Areola "looking in front", ie a distance between point A (at noon at the top of the areola) at the mid-sternal point of about 16 cm to 24 cm * Ptosis (distance between the lowest part of the breast and the furrow under the breast) to a maximum of 7cm (measurement in sitting position) * Expected correction of ptosis by half with reduction of 1 to 3 cup sizes * Good quality thick skin * Affiliated patient or beneficiary of a social security scheme * Patient requesting breast reduction * Patient who signed free and informed consent Exclusion Criteria: * Areola "look down"; point A more than 25 cm * Ptose greater than and equal to 8 cm * Thin skin * Smoker * Patient on anti-coagulant * Patient participating in another clinical study * Protected patient: adults under guardianship, curatorship or other legal protection, deprived of their 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.

What they're measuring

Number of Visible Scare

Timeframe: 3 months

Trial details

NCT IDNCT04597515

SponsorRamsay Générale de Santé

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-30

Contact for this trial

Jean François OUDET

+33683346567 jf.oudet@ecten.eu

View on ClinicalTrials.gov More Breast Hypertrophy trials