Breast HypertrophyR-HTM-RNCT04597515
Reduction of Breast Enlargement Using the Da Vinci Xi Robot
A study testing Robot Breast reduction surgery in people with Breast Hypertrophy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Hypertrophy
- What is being tested?
- Robot Breast reduction surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Good quality thick skin
- Affiliated patient or beneficiary of a social security scheme
- Patient requesting breast reduction
- Patient who signed free and informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé d'Antony
Antony, IDF, 92160
JF OUDET, +33683346567 ext. +33683346567, jf.oudet@ecten.eu
MH barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
About this study
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.
Read the 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.
- Conditions
- Breast Hypertrophy
- Being tested
- Robot Breast reduction surgery
- Keywords
- breast reduction, perimammary
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Breast reduction surgeryProcedure or surgery
Breast reduction surgery, using a robot by removing a breast disc at the base
| Study group | Role | What they receive |
|---|---|---|
| Robot Reduction | Experimental | The project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm . Receives: Procedure: Robot Breast reduction surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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)
Measured: day of surgery
Intensity of Back Pain
The pain score on the EVA scale (score from 0 no pain to 10 max pain) will be described
Measured: 3 months
Skin retraction
- Post-operative skin retraction
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast HypertrophyStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Privé d'Antony - Dr Dunet
- Responsible party
- Sponsor
- Investigators
- Eric Dunet, Dr, Principal investigator, Ramsay santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597515
- Sponsor's protocol ID
- 2019-A01199-48
- Acronym
- R-HTM-R
- Status last verified
- Oct 2020
- First submitted
- 2 Jun 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Breast Enlargement Using the Da Vinci Xi Robot
- ClinicalTrials.gov ID
- NCT04597515
- Acronym / sponsor ID
- R-HTM-R / 2019-A01199-48
- Conditions
- Breast Hypertrophy
- Keywords
- breast reduction, perimammary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Hôpital Privé d'Antony - Dr Dunet
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Robot Reduction | Experimental | Procedure: Robot Breast reduction surgeryThe project consists in removing a breast disc at the base, causing a circular sagging skin cut of 2 to 3 cm . |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (8 listed)
- Areola "look down"; point A more than 25 cm
- Ptose greater than and equal to 8 cm
- Thin skin
- Smoker
- Patient on anti-coagulant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot Breast reduction surgeryBreast reduction surgery, using a robot by removing a breast disc at the base | Procedure or surgery | Robot Reduction |
Primary outcome
Number of Visible Scare
Time frame: 3 months
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 secondary outcomes
Efficacity of the reduction (weight)
Time frame: day of surgery
Intensity of Back Pain
Time frame: 3 months
Skin retraction
Time frame: at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Dunet, Dr principal investigator
Ramsay santé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Breast reduction surgery in people with Breast Hypertrophy, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean François OUDET (+33683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Visible Scare (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.