Reduction of Breast Enlargement Using the Da Vinci Xi Robot
R-HTM-R
1 other identifier
interventional
5
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 22, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedOctober 22, 2020
October 1, 2020
1.1 years
June 2, 2020
October 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Visible Scare
The main judgment criterion for the scar balance will be a photograph of the breasts at 3 months to describe the number of visible scars. Aspect and position.
3 months
Secondary Outcomes (3)
Efficacity of the reduction (weight)
day of surgery
Intensity of Back Pain
3 months
Skin retraction
at 3 months
Other Outcomes (1)
Visible scare number
1 year
Study Arms (1)
Robot Reduction
EXPERIMENTALThe project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm .
Interventions
Breast reduction surgery, using a robot by removing a breast disc at the base
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramsay Générale de Santélead
- Hôpital Privé d'Antony - Dr Dunetcollaborator
Study Sites (1)
Hôpital Privé d'Antony
Antony, IDF, 92160, France
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Dunet, Dr
Ramsay santé
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2020
First Posted
October 22, 2020
Study Start
November 1, 2020
Primary Completion
November 30, 2021
Study Completion
November 30, 2022
Last Updated
October 22, 2020
Record last verified: 2020-10