Breast Cancer FemalesNCT07419971
Influencing Factors and Mechanisms of Capsular Contracture After Prosthesis Reconstruction in Patients With Breast Cancer
An observational study of Breast Cancer Females and Breast Reconstruction, run by West China Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer Females, Breast Reconstruction
- What is being tested?
- synthetic mesh
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Mar 2026
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients who undergoing mastectomy and the implant- based breast reconstruction for breast cancer or prophylactic reasons
Inclusion Criteria: Female adults aged 18 years or older; Undergoing mastectomy for breast cancer or prophylactic reasons; Receiving immediate implant-based reconstruction (either implant-only or combined with an autologous flap) Exclusion Criteria: Delayed reconstruction; Purely autologous reconstruction (without an implant); Incomplete postoperative follow-up data precluding effective aesthetic assessment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery.
- Conditions
- Breast Cancer Females, Breast Reconstruction
- Being tested
- synthetic mesh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synthetic meshProcedure or surgery
Whether synthetic meshes are used in breast cancer patients for immediate breast reconstruction after breast cancer resection
| Study group | Role | What they receive |
|---|---|---|
| Mesh | implant- based breast reconstruction with synthetic mesh Receives: Procedure: synthetic mesh | |
| Without Mesh | implant- based breast reconstruction without synthetic mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic Outcome
Half a year post-IBBR, patients underwent a structured interview and physical examination by two independent senior breast surgeon, blinded to the surgical details, during outpatient visits using the Ueda Aesthetic Scale, "Excellent'" (9-10 points), ''Good'' (7-8points), ''Fair'' (5-6 points) and ''Poor'' (0-4 points).
Measured: From enrollment to the end of follow up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemalesStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing LYU, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419971
- Sponsor's protocol ID
- 2025-766
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 17 Mar 2026
- 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Factors and Mechanisms of Capsular Contracture After Prosthesis Reconstruction in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT07419971
- Acronym / sponsor ID
- 2025-766
- Conditions
- Breast Cancer Females, Breast Reconstruction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Feb 2026 (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 aim of this study is to evaluate the aesthetic outcomes in immediate implant-based breast reconstruction following breast mastectomy surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh | – | Procedure: synthetic meshimplant- based breast reconstruction with synthetic mesh |
| Without Mesh | – | –implant- based breast reconstruction without synthetic mesh |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients who undergoing mastectomy and the implant- based breast reconstruction for breast cancer or prophylactic reasons
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 |
|---|---|---|
| synthetic meshWhether synthetic meshes are used in breast cancer patients for immediate breast reconstruction after breast cancer resection | Procedure or surgery | Mesh |
Primary outcome
Aesthetic Outcome
Time frame: From enrollment to the end of follow up at 6 months
Half a year post-IBBR, patients underwent a structured interview and physical examination by two independent senior breast surgeon, blinded to the surgical details, during outpatient visits using the Ueda Aesthetic Scale, "Excellent'" (9-10 points), ''Good'' (7-8points), ''Fair'' (5-6 points) and ''Poor'' (0-4 points).
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 17 Mar 2026.
- 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.
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 Breast Cancer Females and Breast Reconstruction, run by West China Hospital 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?
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: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. 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?
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?
Aesthetic Outcome (time frame: From enrollment to the end of follow up at 6 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 17 Mar 2026.