Back to resultsReduction of Breast Enlargement Using the Da Vinci Xi Robot (R-HTM-R)
Primary Purpose
Breast Hypertrophy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Robot Breast reduction surgery
Sponsored by
About this trial
This is an interventional device feasibility trial for Breast Hypertrophy focused on measuring breast reduction, perimammary
Eligibility Criteria
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
Sites / Locations
- Hôpital Privé d'AntonyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robot Reduction
Arm Description
The project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm .
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Efficacity of the reduction (weight)
- The weight of the exeresis (more than 300g per side which corresponds according to calculation to a gland disc about 2 cm thick on an extended conical breast of 13cm for the base)
Intensity of Back Pain
The pain score on the EVA scale (score from 0 no pain to 10 max pain) will be described
Skin retraction
- Post-operative skin retraction
Full Information
NCT ID
NCT04597515
First Posted
June 2, 2020
Last Updated
October 16, 2020
Sponsor
Ramsay Générale de Santé
Collaborators
Hôpital Privé d'Antony - Dr Dunet
1. Study Identification
Unique Protocol Identification Number
NCT04597515
Brief Title
Reduction of Breast Enlargement Using the Da Vinci Xi Robot
Acronym
R-HTM-R
Official Title
Reduction of Breast Enlargement Using the Da Vinci Xi Robot
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Hôpital Privé d'Antony - Dr Dunet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloid scarring, especially in young women.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Hypertrophy
Keywords
breast reduction, perimammary
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robot Reduction
Arm Type
Experimental
Arm Description
The project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm .
Intervention Type
Procedure
Intervention Name(s)
Robot Breast reduction surgery
Intervention Description
Breast reduction surgery, using a robot by removing a breast disc at the base
Primary Outcome Measure Information:
Title
Number of Visible Scare
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Efficacity of the reduction (weight)
Description
- The weight of the exeresis (more than 300g per side which corresponds according to calculation to a gland disc about 2 cm thick on an extended conical breast of 13cm for the base)
Time Frame
day of surgery
Title
Intensity of Back Pain
Description
The pain score on the EVA scale (score from 0 no pain to 10 max pain) will be described
Time Frame
3 months
Title
Skin retraction
Description
- Post-operative skin retraction
Time Frame
at 3 months
Other Pre-specified Outcome Measures:
Title
Visible scare number
Description
number of visible scare based on photos analysis
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean François OUDET
Phone
+33683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
MH barba
Phone
+33664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Dunet, Dr
Organizational Affiliation
Ramsay santé
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Privé d'Antony
City
Antony
State/Province
IDF
ZIP/Postal Code
92160
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JF OUDET
Phone
+33683346567
Ext
+33683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name & Degree
MH barba
Phone
+330664888704
Ext
+330664888704
Email
mh.barba@ecten.eu
First Name & Middle Initial & Last Name & Degree
Eric Dunet
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Reduction of Breast Enlargement Using the Da Vinci Xi Robot
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