Breast ReductionR-HTM-RNCT05822115
Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
A study testing Reduction of breast hypertrophy by means of laparoscopic in people with Breast Reduction, run by Groupe Hospitalier Nord-Essonne at 1 site in France.
Trial summary
The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy. This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy. 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 Reduction
- What is being tested?
- Reduction of breast hypertrophy by means of laparoscopic
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2023to Sep 2024
- 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
- Women over the age of 18.
- Category 1 or 2 according to the Regnault classification.
- C cup breast size or larger.
- Areola "looks ahead" i.e. a distance between point A (at the top of the areola) at the median suprasternal point of approximately 16 cm to 24 cm.
- Ptosis (distance between the lowest part of the breast and the submammary fold) of a maximum of 7cm (measured in a seated position).
- Expected correction of half ptosis with decrease of 1 to 3 cup sizes.
Show all 19Show fewer
- Patient has good quality thick skin.
- Social security scheme.
- Patient requesting breast reduction.
- Patient having signed the free and informed consent.
- Non inclusion criteria :
- Areola "look down"; point A more than 25 cm.
- Ptosis greater than or equal to 8 cm.
- Thin skin.
- Smoker.
- Patient under effects of anti-coagulant.
- Patient participating in another clinical study.
- Protected patient: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- Pregnant, lactating woman.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Dr Eric DUNET
Longjumeau, 91160
Dr Eric Dunet Principal investigator, ericdunet@gmail.com
About this study
The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy.
This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.
Read the detailed description
Breast reductions are common procedures. One of the main difficulties related to this surgery remains the healing, wide at the peri-areolar level, vertical at the sub-areolar level and in the sub-mammary fold. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloidal healing, especially in young subjects.
On This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result without scarring in the context of the reduction of medium volume breast hypertrophy.
Ultimately, the results of this study may serve as a basis for further research by proposing:
- Prophylactic mastectomies and immediate breast reconstruction without lateral scar and with a less visible sub-breast scar.
- A breast reduction in young patients before the skin undergoes the effects of the heaviness of the breasts.
- Conditions
- Breast Reduction
- Being tested
- Reduction of breast hypertrophy by means of laparoscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduction of breast hypertrophy by means of laparoscopicDevice
Also called R-HTM-R
The research procedure is a breast reduction performed by means of laparoscopic surgery.
The project consists of removing a disc from the breast at the level of the base, thus causing peripheral skin slackening of 2 to 3 cm but circular. Both breasts are usually operated on at the same time. In case of asymmetry, only one side will be treated.
| Study group | Role | What they receive |
|---|---|---|
| treated group | Experimental | Breast reduction Receives: Device: Reduction of breast hypertrophy by means of laparoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photography of the scar
centimeter
Measured: at 3 months
Secondary outcomes (10)
Scar assessment
number of scars
Measured: at 3 weeks
Resection weight
Resection weight
Measured: at 0 day
Photography of Areola
Centimeter
Measured: at 3 weeks, 3 months and 1 year
Scar lenght
Centimeter
Measured: at 3 weeks, 3 months and 1 year
Blood loss
the haemoglobin (hb) level
Measured: at 1 day
Pain scale
0 (no pain) to 10 (very intense pain)
Measured: at 3 weeks, 3 months and 1 year
Satisfaction scale
0 (dissatisfied) to 10 (satisfied)
Measured: at 3 weeks, 3 months and 1 year
Cancer
presence or absence
Measured: at day 0
Macroeconomic impact
length of hospital stay, duration of surgery
Measured: at 1 year
Scar thickness
Centimeter
Measured: at 3 weeks, 3 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start24 Apr 2023
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReductionStudies of the same condition, open and under way.
- 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
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Nord-Essonne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822115
- Sponsor's protocol ID
- 2022-A01278-35
- Acronym
- R-HTM-R
- Status last verified
- Mar 2023
- First submitted
- 21 Mar 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- 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 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Breast Hypertrophy by Means of Coelioscopique Surgery
- ClinicalTrials.gov ID
- NCT05822115
- Acronym / sponsor ID
- R-HTM-R / 2022-A01278-35
- Conditions
- Breast Reduction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Nord-EssonneUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 20 Apr 2023 (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.
The objective of this interventional study is based on the hypothesis that coelioscopique surgery could be used to reduce breast hypertrophy.
This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result in the context of reduction of medium volume breast hypertrophy.
Detailed description
Breast reductions are common procedures. One of the main difficulties related to this surgery remains the healing, wide at the peri-areolar level, vertical at the sub-areolar level and in the sub-mammary fold. In addition, this intervention remains subject to the vagaries of hypertrophic or even keloidal healing, especially in young subjects.
On This study can be expected to scientifically validate the use of laparoscopic surgery to obtain a clinical result without scarring in the context of the reduction of medium volume breast hypertrophy.
Ultimately, the results of this study may serve as a basis for further research by proposing:
- Prophylactic mastectomies and immediate breast reconstruction without lateral scar and with a less visible sub-breast scar.
- A breast reduction in young patients before the skin undergoes the effects of the heaviness of the breasts.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treated group | Experimental | Device: Reduction of breast hypertrophy by means of laparoscopicBreast reduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Women over the age of 18.
- Category 1 or 2 according to the Regnault classification.
- C cup breast size or larger.
- Areola "looks ahead" i.e. a distance between point A (at the top of the areola) at the median suprasternal point of approximately 16 cm to 24 cm.
- Ptosis (distance between the lowest part of the breast and the submammary fold) of a maximum of 7cm (measured in a seated position).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Reduction of breast hypertrophy by means of laparoscopicAlso: R-HTM-RThe research procedure is a breast reduction performed by means of laparoscopic surgery. The project consists of removing a disc from the breast at the level of the base, thus causing peripheral skin slackening of 2 to 3 cm but circular. Both breasts are usually operated on at the same time. In case of asymmetry, only one side will be treated. | Device | treated group |
Primary outcome
Photography of the scar
Time frame: at 3 months
centimeter
10 secondary outcomes
Scar assessment
Time frame: at 3 weeks
Resection weight
Time frame: at 0 day
Photography of Areola
Time frame: at 3 weeks, 3 months and 1 year
Scar lenght
Time frame: at 3 weeks, 3 months and 1 year
Blood loss
Time frame: at 1 day
Pain scale
Time frame: at 3 weeks, 3 months and 1 year
Satisfaction scale
Time frame: at 3 weeks, 3 months and 1 year
Cancer
Time frame: at day 0
Macroeconomic impact
Time frame: at 1 year
Scar thickness
Time frame: at 3 weeks, 3 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduction of breast hypertrophy by means of laparoscopic in people with Breast Reduction, run by Groupe Hospitalier Nord-Essonne 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 19 inclusion and 0 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 9 May 2023. 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 Eric Dr DUNET, Chirurgien (+33607812501, ericdunet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Photography of the scar (time frame: at 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 9 May 2023.