Breast DiseaseNCT06678776
Endoscopic Anatomy of the Breast Fascia System
An observational study of Breast Disease and Anatomy, run by Haiyan Li at 1 site in China.
Trial summary
This study will focus on two key theories: the development theory of the breast fascia system and the reverse development theory. The research findings indicate that breast development generally follows a growth pattern from anterior to posterior, and from central to peripheral regions. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Disease, Anatomy
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 184 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 30 Dec 2024
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inpatients of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University.
Who may be able to join
- Breast cancer patients who need mastectomy and patients who need breast reduction during the study period.
Who cannot join
- breast conserving surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Haiyan Li, Doctor, +86 15813340604, lihy27@mail.sysu.edu.cn
About this study
Official title: Endoscopic Anatomy of the Breast Fascia System: A Reverse Development Theory
This study will focus on two key theories: the development theory of the breast fascia system and the reverse development theory. The research findings indicate that breast development generally follows a growth pattern from anterior to posterior, and from central to peripheral regions. However, an intriguing phenomenon contradicting this developmental process was discovered through endoscopic mastectomy, which has not been previously discussed. Based on the aforementioned theoretical analysis, this study includes patients who underwent endoscopic and reduction mammaplasty in the Department of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University. The investigators proposed the following research framework: firstly, comprehensively understanding the structure of the breast fascia and the sequence of breast development through endoscope and existing research; secondly, exploring the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty; lastly, proposing a reverse development theory for breast fascia based on these theories in order to provide standardized and procedural guidance for breast surgeons.
- Conditions
- Breast Disease, Anatomy
- Being tested
- surgery
- Medical subject headings
- Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Explore the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Surgery | patients who underwent endoscopic breast surgery Receives: Procedure: surgery | |
| Reduction Mammaplasty | patients who underwent reduction mammaplasty Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of ligaments
The identification of ligaments primarily relies on the observation of membranous structures, and record the number of cases.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jun 2019
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haiyan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haiyan Li, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678776
- Sponsor's protocol ID
- 2024ZSLYEC-560
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The corresponding database has not been established yet.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Anatomy of the Breast Fascia System: A Reverse Development Theory
- ClinicalTrials.gov ID
- NCT06678776
- Acronym / sponsor ID
- 2024ZSLYEC-560
- Conditions
- Breast Disease, Anatomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Haiyan LiUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 7 Nov 2024 (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.
This study will focus on two key theories: the development theory of the breast fascia system and the reverse development theory. The research findings indicate that breast development generally follows a growth pattern from anterior to posterior, and from central to peripheral regions. However, an intriguing phenomenon contradicting this developmental process was discovered through endoscopic mastectomy, which has not been previously discussed. Based on the aforementioned theoretical analysis, this study includes patients who underwent endoscopic and reduction mammaplasty in the Department of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University. The investigators proposed the following research framework: firstly, comprehensively understanding the structure of the breast fascia and the sequence of breast development through endoscope and existing research; secondly, exploring the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty; lastly, proposing a reverse development theory for breast fascia based on these theories in order to provide standardized and procedural guidance for breast surgeons.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Surgery | – | Procedure: surgerypatients who underwent endoscopic breast surgery |
| Reduction Mammaplasty | – | Procedure: surgerypatients who underwent reduction mammaplasty |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inpatients of Breast Surgery in the Sixth Affiliated Hospital of Sun Yat-sen University.
Key inclusion criteria (1 listed)
- Breast cancer patients who need mastectomy and patients who need breast reduction during the study period.
Key exclusion criteria (1 listed)
- breast conserving surgery
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 |
|---|---|---|
| surgeryExplore the relationship between breast fascia development and surgical processes by repeatedly observing surgical videos of endoscopic mastectomy and reduction mammaplasty. | Procedure or surgery | Endoscopic Surgery, Reduction Mammaplasty |
Primary outcome
Identification of ligaments
Time frame: 1 year
The identification of ligaments primarily relies on the observation of membranous structures, and record the number of cases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: Undecided. The corresponding database has not been established yet.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Disease and Anatomy, run by Haiyan Li at 1 site in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 7 Nov 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Li, doctor (+86 15813340604, lihy27@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of ligaments (time frame: 1 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 7 Nov 2024.