Breast Asymmetry, 3DMENABREANCT03715738
MEasurement by a Numerical Approach of BREAst Volume
A study testing arm 1 : Creaform3D + MyotonPRO in people with Breast Asymmetry, 3D, run by University Hospital, Angers at 1 site in France.
Trial summary
Breast asymmetry is a rare in plastic surgery. In majority of cases, it is idiopathic. In cases that are poorly tolerated physically (vertebral imbalance, posture disorders) or psychologically, the decision to perform breast symmetrization surgery can be made. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Asymmetry, 3D
- What is being tested?
- arm 1 : Creaform3D + MyotonPRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2019to 18 Sep 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred for uni / bilateral breast reduction as part of an indication of surgical management.
- Major patients.
- Patients affiliated or beneficiaries of a social security scheme
- Patients who have signed prior informed consent.
Who cannot join
- Protected patients (pregnant, parturient and lactating women, persons deprived of their liberty by an administrative or judicial decision, persons undergoing psychiatric care under duress, minors, adults over the age of 18) legal protection measure or unable to express their consent).
- Patients unfit to understand the objectives or instructions of the study.
- Patients in an exclusion period relative to another interventional study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MEasurement by a Numerical Approach of BREAst Volume MENABREA
Breast asymmetry is a rare in plastic surgery. In majority of cases, it is idiopathic.
In cases that are poorly tolerated physically (vertebral imbalance, posture disorders) or psychologically, the decision to perform breast symmetrization surgery can be made. It is recommended to do this surgery after a slimming treatment if the woman is overweight or after pregnancy that causes a change in the structure and volume of the chest. In fact, the weight variations deteriorate the long-term result.
Read more
However, this surgical management remains difficult. In fact, the volume to be removed (unilateral breast reduction) to be symmetrized is a function of the volume of the contralateral breast and the preoperative drawings are made while standing. Currently, the evaluation of the volume to be removed remains subjective and is based on the experience of the surgeon. In addition, intraoperatively, this evaluation is also subjective because the patient is lying down which changes the position of the anatomical landmarks: the optimization of the symmetrization is only possible by the eye and the touch.
No measuring device is currently used to assess the difference in volume between the 2 breasts and guide the surgeon in the volume (or weight) to remove. It is therefore sometimes necessary to perform a second intervention in case of residual postoperative asymmetry.
Primary objective :
To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO).
Second objective : To study the association between the weight of tissues removed during the procedure and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland estimated by manual palpation (Likert scale from 1 to 5).
- Conditions
- Breast Asymmetry, 3D
- Being tested
- arm 1 : Creaform3D + MyotonPRO
- Medical subject headings
- Anisomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arm 1 : Creaform3D + MyotonPROOther
After inclusion,are carried out:
- estimation of the volume of the breast to be reduced with the 3D digital camera
- measurement of breast density by Likert scale and MyotonPRO
The volumetric measurement of the breast is performed using the 3D digital camera. The patient is bent forward with hands resting on a chair to be as still as possible over a period of 30 seconds to 1 minute. The 3D digital camera rotates around the breast to capture the volume of the breast.
In peroperative, the weight of tissues removed is weighed (in grams). The removed weight is recorded in the observation notebook.
In postoperative (4 months), the possible long-term complications related to the intervention (mainly the dissatisfaction of the patient as for the aesthetic result) are collected then a new acquisition of the mammary volume is carried out with the digital camera 3D.
Once this measurement is completed, participation in the study is complete.
| Study group | Role | What they receive |
|---|---|---|
| arm 1 : Creaform3D + MyotonPRO | Experimental | A clinical questionnaire is completed by the investigator (chest circumference, thorax turn, breast "measurements").
The breast density is assessed by the surgeon and scored from 1 to 5 (Likert scale) and then by the MyotonPRO The volumetric measurement of the breast is performed using the 3D digital camera. The patient is bent forward with hands resting on a chair during 30 seconds to 1 minute. The 3D digital camera rotates around the breast to capture the volume of the breast.
Intraoperatively, the weight of tissues removed is weighed (in grams), recorded in the observation notebook.
In post-operative (4 months), the possible long-term complications related to the intervention (mainly the dissatisfaction of the patient as for the aesthetic result) are collected then a new acquisition of the mammary volume is carried out with the digital camera 3D.
Once this measurement is completed, participation in the study is complete Receives: Other: arm 1 : Creaform3D + MyotonPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
association between weight and volume adjusted to the density of the gland measured by electronic palpation
To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO).
Primary judgment criterion:
Coefficient associated with volume variation in the linear regression model (model 1) explaining weight by volume variation and density measured by electronic palpation.
Measured: one year
Secondary outcomes (2)
association between weight and volume adjusted to the density of the gland estimated by manual palpation
To study the association between the weight of tissues removed during the procedure and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland estimated by manual palpation (Likert scale from 1 to 5).
Secondary judgment criterion 1:
Coefficient associated with volume variation in the linear regression model (Model 2) explaining weight by volume variation and estimated density by manual palpation.
Measured: one year
comparison of models 1 and 2
Comparison of models 1 and 2 (estimated density by manual palpation or measured by electronic method), to see if one model is better than the other.
Secondary judgment criterion 2:
Akaike Criterion
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start2 Jul 2019
- Primary completion18 Apr 2023
- Study completion18 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Asymmetry, 3DStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715738
- Sponsor's protocol ID
- 2018-A02018-47
- Acronym
- MENABREA
- Status last verified
- Dec 2024
- First submitted
- 30 Aug 2018
- Last updated
- 30 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEasurement by a Numerical Approach of BREAst Volume MENABREA
- ClinicalTrials.gov ID
- NCT03715738
- Acronym / sponsor ID
- MENABREA / 2018-A02018-47
- Conditions
- Breast Asymmetry, 3D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 2 Jul 2019 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Sep 2023 (actual)
- First posted
- 23 Oct 2018 (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 asymmetry is a rare in plastic surgery. In majority of cases, it is idiopathic.
In cases that are poorly tolerated physically (vertebral imbalance, posture disorders) or psychologically, the decision to perform breast symmetrization surgery can be made. It is recommended to do this surgery after a slimming treatment if the woman is overweight or after pregnancy that causes a change in the structure and volume of the chest. In fact, the weight variations deteriorate the long-term result.
However, this surgical management remains difficult. In fact, the volume to be removed (unilateral breast reduction) to be symmetrized is a function of the volume of the contralateral breast and the preoperative drawings are made while standing. Currently, the evaluation of the volume to be removed remains subjective and is based on the experience of the surgeon. In addition, intraoperatively, this evaluation is also subjective because the patient is lying down which changes the position of the anatomical landmarks: the optimization of the symmetrization is only possible by the eye and the touch.
No measuring device is currently used to assess the difference in volume between the 2 breasts and guide the surgeon in the volume (or weight) to remove. It is therefore sometimes necessary to perform a second intervention in case of residual postoperative asymmetry.
Primary objective :
To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO).
Second objective : To study the association between the weight of tissues removed during the procedure and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland estimated by manual palpation (Likert scale from 1 to 5).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| arm 1 : Creaform3D + MyotonPRO | Experimental | Other: arm 1 : Creaform3D + MyotonPROA clinical questionnaire is completed by the investigator (chest circumference, thorax turn, breast "measurements"). The breast density is assessed by the surgeon and scored from 1 to 5 (Likert scale) and then by the MyotonPRO The volumetric measurement of the breast is performed using the 3D digital camera. The patient is bent forward with hands resting on a chair during 30 seconds to 1 minute. The 3D digital camera rotates around the breast to capture the volume of the breast. Intraoperatively, the weight of tissues removed is weighed (in grams), recorded in the observation notebook. In post-operative (4 months), the possible long-term complications related to the intervention (mainly the dissatisfaction of the patient as for the aesthetic result) are collected then a new acquisition of the mammary volume is carried out with the digital camera 3D. Once this measurement is completed, participation in the study is complete |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients referred for uni / bilateral breast reduction as part of an indication of surgical management.
- Major patients.
- Patients affiliated or beneficiaries of a social security scheme
- Patients who have signed prior informed consent.
Key exclusion criteria (3 listed)
- Protected patients (pregnant, parturient and lactating women, persons deprived of their liberty by an administrative or judicial decision, persons undergoing psychiatric care under duress, minors, adults over the age of 18) legal protection measure or unable to express their consent).
- Patients unfit to understand the objectives or instructions of the study.
- Patients in an exclusion period relative to another interventional study.
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 |
|---|---|---|
| arm 1 : Creaform3D + MyotonPROAfter inclusion,are carried out: * estimation of the volume of the breast to be reduced with the 3D digital camera * measurement of breast density by Likert scale and MyotonPRO The volumetric measurement of the breast is performed using the 3D digital camera. The patient is bent forward with hands resting on a chair to be as still as possible over a period of 30 seconds to 1 minute. The 3D digital camera rotates around the breast to capture the volume of the breast. In peroperative, the weight of tissues removed is weighed (in grams). The removed weight is recorded in the observation notebook. In postoperative (4 months), the possible long-term complications related to the intervention (mainly the dissatisfaction of the patient as for the aesthetic result) are collected then a new acquisition of the mammary volume is carried out with the digital camera 3D. Once this measurement is completed, participation in the study is complete. | Other | arm 1 : Creaform3D + MyotonPRO |
Primary outcome
association between weight and volume adjusted to the density of the gland measured by electronic palpation
Time frame: one year
To study the association between the weight of tissues removed during the intervention and the variation of the breast volume (pre / postoperative) measured by the Créaform® GOPRO 3D digital camera adjusted on the density of the gland measured by electronic palpation (MyotonPRO). Primary judgment criterion: Coefficient associated with volume variation in the linear regression model (model 1) explaining weight by volume variation and density measured by electronic palpation.
2 secondary outcomes
association between weight and volume adjusted to the density of the gland estimated by manual palpation
Time frame: one year
comparison of models 1 and 2
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing arm 1 : Creaform3D + MyotonPRO in people with Breast Asymmetry, 3D, run by University Hospital, Angers 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 30 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
association between weight and volume adjusted to the density of the gland measured by electronic palpation (time frame: one year). 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 30 Dec 2024.