Reduction of Breast Enlargement Using the Da Vinci Xi Robot
NCT ID: NCT04597515
Last Updated: 2020-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
5 participants
INTERVENTIONAL
2020-11-01
2022-11-30
Brief Summary
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The expected result is to achieve a reduction in breast enlargement with no visible scar using Da Da Vinci Xi robot.
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Detailed Description
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The current research project is based on the hypothesis that the same technique could be used in the context of a reduction of breast enlargement on a smaller surface allowing the determination of a perimammary "halo" of scar retraction. The project consists in removing a breast disc at the base, thus causing a sagging skin cut of 2 to 3 cm but this time, circular.
The expected result is to achieve a reduction in breast enlargement with no visible scar, using Da Vinci Xi robot.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Robot Reduction
The project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm .
Robot Breast reduction surgery
Breast reduction surgery, using a robot by removing a breast disc at the base
Interventions
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Robot Breast reduction surgery
Breast reduction surgery, using a robot by removing a breast disc at the base
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Hôpital Privé d'Antony - Dr Dunet
UNKNOWN
Ramsay Générale de Santé
OTHER
Responsible Party
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Principal Investigators
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Eric Dunet, Dr
Role: PRINCIPAL_INVESTIGATOR
Ramsay santé
Locations
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Hôpital Privé d'Antony
Antony, IDF, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-A01199-48
Identifier Type: -
Identifier Source: org_study_id
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