Endoscopic Breast SurgeryNCT06472700
Endoscopic Extirpation of Benign Breast Tumors Using a Lateral Chest Wall Incision
An observational study of Endoscopic Breast Surgery and Benign Breast Tumors, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
1. A new surgical method for breast surgery has been introduced, which involves the removal of benign breast tumors through endoscopic surgery, thereby avoiding noticeable scarring on the breast. 2. The feasibility of this surgery, key technical points, and potential complications have been analyzed. Read more about this study
- Who is it for?
- Ages 14 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endoscopic Breast Surgery, Benign Breast Tumors
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Nov 2023
- Phase
- Observational
- 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 14 to 42 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study population consisted of patients diagnosed with benign breast tumors. The demographic characteristics included: Age: Patients aged 14-42 years old Gender: Female Ethnicity: Diverse ethnic backgrounds, primarily Han Chinese Inclusion Criteria: 1. Female breast benign tumor patients 2. Received endoscopic resection of benign breast tumors via a lateral chest wall approach. Exclusion Criteria: Patients who are unable to comply with follow-up requirements Sample Size: A total of 42 patients were included in the study Geographical Location: Patients were recruited from Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Who may be able to join
- Female breast benign tumor patients
- Received endoscopic resection of benign breast tumors via a lateral chest wall approach.
Who cannot join
- Patients who are unable to comply with follow-up requirements
- Patients with a history of breast sugery
- Breast cancer patients
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510000
About this study
Official title: The Feasibility Analysis of Endoscopic Extirpation of Benign Breast Tumors Using Lateral Chest Wall Incision: The Feasibility Analysis of Minimally Invasive Excision for Benign Breast Tumors Via Lateral Chest Wall Approach
- A new surgical method for breast surgery has been introduced, which involves the removal of benign breast tumors through endoscopic surgery, thereby avoiding noticeable scarring on the breast.
- The feasibility of this surgery, key technical points, and potential complications have been analyzed.
- Conditions
- Endoscopic Breast Surgery, Benign Breast Tumors
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| observation group | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmetic Outcome After Endoscopic Benign Breast Tumor Resection
Through outpatient questionnaires and physician-rated photo evaluations
Measured: 1-3 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Oct 2021
- Primary completion31 Aug 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Breast SurgeryStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinghua Zhao, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472700
- Sponsor's protocol ID
- SunYatsenU8H
- Status last verified
- Jun 2024
- First submitted
- 15 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility Analysis of Endoscopic Extirpation of Benign Breast Tumors Using Lateral Chest Wall Incision: The Feasibility Analysis of Minimally Invasive Excision for Benign Breast Tumors Via Lateral Chest Wall Approach
- ClinicalTrials.gov ID
- NCT06472700
- Acronym / sponsor ID
- SunYatsenU8H
- Conditions
- Endoscopic Breast Surgery, Benign Breast Tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 25 Jun 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.
- A new surgical method for breast surgery has been introduced, which involves the removal of benign breast tumors through endoscopic surgery, thereby avoiding noticeable scarring on the breast.
- The feasibility of this surgery, key technical points, and potential complications have been analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Other: No intervention |
Who may qualify
- Ages
- 14 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population consisted of patients diagnosed with benign breast tumors. The demographic characteristics included: Age: Patients aged 14-42 years old Gender: Female Ethnicity: Diverse ethnic backgrounds, primarily Han Chinese Inclusion Criteria: 1. Female breast benign tumor patients 2. Received endoscopic resection of benign breast tumors via a lateral chest wall approach. Exclusion Criteria: Patients who are unable to comply with follow-up requirements Sample Size: A total of 42 patients were included in the study Geographical Location: Patients were recruited from Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Key inclusion criteria (2 listed)
- Female breast benign tumor patients
- Received endoscopic resection of benign breast tumors via a lateral chest wall approach.
Key exclusion criteria (3 listed)
- Patients who are unable to comply with follow-up requirements
- Patients with a history of breast sugery
- Breast cancer patients
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 |
|---|---|---|
| No interventionNo intervention | Other | observation group |
Primary outcome
Cosmetic Outcome After Endoscopic Benign Breast Tumor Resection
Time frame: 1-3 months post-surgery.
Through outpatient questionnaires and physician-rated photo evaluations
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 25 Jun 2024.
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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.
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?
An observational study of Endoscopic Breast Surgery and Benign Breast Tumors, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 2 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 25 Jun 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?
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?
Cosmetic Outcome After Endoscopic Benign Breast Tumor Resection (time frame: 1-3 months post-surgery.). 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 25 Jun 2024.