Breast CancerNCT07365267
Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy
A study testing Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh in people with Breast Cancer and Breast Reconstruction After Mastectomy, run by Xijing Hospital at 1 site in China.
Trial summary
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction After Mastectomy, 3D-Printed Biodegradable Biological Mesh
- What is being tested?
- Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2026to 1 Dec 2028
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female breast cancer patients aged 18 to 70 years.
- Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines.
- Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.
- ECOG performance status of 0-1.
- Voluntary participation in the study and signing of the written informed consent form.
Who cannot join
- Age >70 years.
- Metastatic breast cancer (Stage IV) at initial diagnosis.
- Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.
- Tumor involvement of the nipple-areolar complex.
- Breast cancer during pregnancy.
- History of other malignancies within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer.
- Abnormal function of vital organs such as heart, lungs, liver, or kidneys; poorly controlled diabetes, etc., rendering the patient unable to tolerate surgery.
- Patients deemed unsuitable for participation by the investigator.
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 First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi, 710032
Ju Liang Zhang, MD, 029-84775271, vascularzhang@163.com
About this study
Official title: Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy :A Prospective, Single-Center, Single-Arm Clinical Study
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.
Read the detailed description
Study Objectives
- Primary Objective: To evaluate the clinical efficacy and safety of breast reconstruction using a 3D- printed biodegradable biological mesh.
- Secondary Objective: To evaluate the postoperative quality of life and breast cancer-free interval after breast reconstruction with a 3D-printed biodegradable biological mesh.
Treatment Plan
- Study Enrollment and Informed Consent: All subjects will sign the relevant informed consent forms before surgery.
- Preoperative Assessment: Patients will complete the Chinese version of the BREAST-Q V2.0 scale and the QoL (Quality of Life) scale.
- Preoperative Imaging Assessment:
Enrolled patients will undergo a preoperative thin-slice breast MRI (3.0T) using a multi-channel phased-array dedicated breast coil. The patient will be in a prone position, head-first. The operator will assist in placing the breast in the center of the coil, allowing it to hang naturally without compression to maintain its natural shape. The prone position also helps reduce respiratory motion artifacts. The patient's arms will be placed naturally in front of their head, avoiding the scan field to reduce artifacts. A high-pressure injector will be connected to an intravenous catheter. An axial three-dimensional thin- slice scan will be selected to display both breasts simultaneously, showing the radially arranged ducts converging towards the nipple and the glandular tissue in the axillary tail. The 3D thin-slice scan facilitates sagittal and coronal reconstructions. The scan range will cover the superior and inferior borders of both breasts.
Conventional Plain Scan: A SE T1WI sequence will be used to obtain T1-weighted transverse images. Scan parameters: TR 500ms, TE 15ms, slice thickness 2.8mm, FOV for both breasts 360mm, matrix 256x320, NEX 2.
Functional Imaging: A FLASH (Fast Low Angle Shot) sequence will be used for 3D dynamic contrast-enhanced scanning. Scan parameters: TR 4.42ms, TE 1.41ms, flip angle 12 degrees, FOV for both breasts 360mm, matrix 512x384, slice thickness 1.2mm, 6 acquisitions, total time 6 minutes 19 seconds, one acquisition 55 seconds. The contrast agent will be Gd-DTPA at a dose of 0.2 mmol/kg, administered as a bolus injection via an antecubital or dorsal hand vein at a rate of 3 ml/s, followed by a 20 ml saline flush at the same rate. After the first scan, the automatic high-pressure injector will be activated to inject the Gd-DTPA contrast agent and saline. The enhanced scan will be initiated simultaneously with the injection and repeated 5 times. The post-enhancement images will be subtracted from the initial plain scan images to obtain 5 sets of subtracted images. These subtracted images will then be reconstructed using the Maximum Intensity Projection (MIP) method to generate 5 three-dimensional enhanced images.
- Preoperative Implant Size Assessment: The implant volume will be estimated using empirical methods to determine the proposed implant size.
- Surgical Simulation, Design, and 3D Printing of PCL Mesh:
Using medical-grade polycaprolactone (PCL) microspheres as the printing material, the optimized breast mesh model will be manufactured using Selective Laser Sintering (SLS) technology. The model data will be processed by slicing software, and the processed data will be input into the SLS printer. The SLS printer will control the laser scanning path according to the contour and filling structure of the current layer to sinter the PCL powder. This process is repeated layer by layer to print the model structure. After printing, the structure is removed, residual powder on the surface is cleaned off, and the final product is sterilized with low-temperature ethylene oxide for 48 hours before use.
- Surgery:Nipple-sparing subcutaneous mastectomy combined with an implant for immediate breastreconstruction will be performed according to standard clinical practice. The choice of incision will be at the surgeon's discretion. Intraoperatively, tissue from behind the nipple will be sent for frozen section histopathological examination. If the margin is positive, the nipple-areolar complex will be resected following safety principles. The 3D-printed biodegradable biological mesh will be used to wrap the silicone implant, which is then placed in the subcutaneous tissue. The wound will be soaked and irrigated with sterile distilled water and normal saline. After achieving thorough hemostasis, a drain will be placed, and the skin will be closed in layers.
- Postoperative Management:Electronic health records will be established. Follow-ups will be conducted at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery, and then every 6 months thereafter. Follow-up content includes recording complications or adverse reactions, completing the Chinese version of the BREAST-Q V2.0 scale for breast aesthetics, satisfaction, and QoL assessment, and monitoring for metastasis or recurrence.
- Conditions
- Breast Cancer, Breast Reconstruction After Mastectomy, 3D-Printed Biodegradable Biological Mesh
- Being tested
- Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh
- Keywords
- 3D-Printed Biodegradable Biological Mesh, breast reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable meshProcedure or surgery
Nipple-sparing subcutaneous mastectomy combined with an implant for immediate breast reconstruction will be performed according to standard clinical practice. The choice of incision will be at the surgeon's discretion. Intraoperatively, tissue from behind the nipple will be sent for frozen section histopathological examination. If the margin is positive, the nipple-areolar complex will be resected following safety principles. The 3D-printed biodegradable biological mesh will be used to wrap the silicone implant, which is then placed in the subcutaneous tissue. The wound will be soaked and irrigated with sterile distilled water and normal saline. After achieving thorough hemostasis, a drain will be placed, and the skin will be closed in layers.
| Study group | Role | What they receive |
|---|---|---|
| 3D printing patient | Experimental | immediate breast reconstruction using 3D-Printed Biodegradable Biological Mesh combined with a silicone breast prosthesis Receives: Procedure: Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative cosmetic results and safety
Postoperative Cosmetic Outcome and Safety: Patient satisfaction will be scored using the reconstruction module of the Breast-Q questionnaire, which includes satisfaction with breasts, satisfaction with surgical outcome, and satisfaction with treatment. Satisfaction with breasts will be the primary endpoint of this study. After the BREAST-Q questionnaire is completed, its score, known as the Q-SCORE, will be calculated. The specific evaluation requires the use of Q-SCORE scoring software. The Breast-Q scale also includes scores for satisfaction with surgery, satisfaction with treatment, and health-related quality of life (QOL), covering physical, psychosocial, and sexual well-being. For all dimensions, a higher patient-reported score indicates higher satisfaction and better quality of life.In outcome of BREAST-Q questionnaire, BREAST-Q scales (domains) are scored on a 0-100 range, with higher scores indicating greater satisfaction or better health-related quality of life.
Measured: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Secondary outcomes (4)
Recurrence-Free Survival (RFS)
Recurrence in the ipsilateral breast, chest wall, skin, or surgical scar confirmed by imaging is defined as "local recurrence day" on the date of the earliest imaging finding. If local recurrence is diagnosed based on clinical history and physical examination, the date of clinical determination is the "local recurrence day." If diagnosed by cytology or histopathology, the date of the earliest examination is the "local recurrence day." RFS is the time from the date of surgery to the date of disease recurrence or death. For patients with no observed recurrence or death, the follow-up is censored at the date of the last confirmation of no recurrence. An increase in tumor markers such as CEA alone is not sufficient to diagnose recurrence.
Measured: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Disease-Free Survival (DFS)
The time from the date of surgery to the date of tumor recurrence (if the specific date of recurrence is unknown, the date of death due to the tumor is used). For patients with no observed recurrence or death, the follow-up is censored at the date of the last confirmation of no recurrence (last date of no recurrence confirmation: the last date of outpatient visit or examination).
Measured: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Overall Survival (OS)
The time from the date of surgery to death from any cause (if death has not occurred, the time to the last follow-up). For surviving patients, the follow-up is censored at the date of the last confirmation of survival. For patients lost to follow-up, it is censored at the last date of confirmed survival before being lost.
Measured: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Surgical Technical Safety (Complication Rate)
Intraoperative complications: Including but not limited to: intraoperative bleeding, major vessel injury, subcutaneous emphysema, hypercapnia, etc. The rate is calculated as the number of patients with any intraoperative complication divided by the total number of patients who underwent surgery.
Postoperative complications: Including but not limited to: infection, skin flap or nipple-areolar complex necrosis, sensory abnormalities in the surgical area, mesh-related complications, etc. The rate is calculated as the number of patients with any postoperative complication divided by the total number of patients who underwent surgery.
Unplanned reoperation rate: The proportion calculated as the number of patients undergoing unplanned reoperation divided by the total number of patients who underwent surgery.
Measured: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start15 Jan 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Juliang-1, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365267
- Sponsor's protocol ID
- KY20252568-F-1
- Status last verified
- Dec 2025
- First submitted
- 8 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy :A Prospective, Single-Center, Single-Arm Clinical Study
- ClinicalTrials.gov ID
- NCT07365267
- Acronym / sponsor ID
- KY20252568-F-1
- Conditions
- Breast Cancer, Breast Reconstruction After Mastectomy, 3D-Printed Biodegradable Biological Mesh
- Keywords
- 3D-Printed Biodegradable Biological Mesh, breast reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Jan 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.
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradable mesh in implant-based breast reconstruction, assess its influence on tissue regeneration, postoperative cosmetic result, and complication profile.
Detailed description
Study Objectives
- Primary Objective: To evaluate the clinical efficacy and safety of breast reconstruction using a 3D- printed biodegradable biological mesh.
- Secondary Objective: To evaluate the postoperative quality of life and breast cancer-free interval after breast reconstruction with a 3D-printed biodegradable biological mesh.
Treatment Plan
- Study Enrollment and Informed Consent: All subjects will sign the relevant informed consent forms before surgery.
- Preoperative Assessment: Patients will complete the Chinese version of the BREAST-Q V2.0 scale and the QoL (Quality of Life) scale.
- Preoperative Imaging Assessment:
Enrolled patients will undergo a preoperative thin-slice breast MRI (3.0T) using a multi-channel phased-array dedicated breast coil. The patient will be in a prone position, head-first. The operator will assist in placing the breast in the center of the coil, allowing it to hang naturally without compression to maintain its natural shape. The prone position also helps reduce respiratory motion artifacts. The patient's arms will be placed naturally in front of their head, avoiding the scan field to reduce artifacts. A high-pressure injector will be connected to an intravenous catheter. An axial three-dimensional thin- slice scan will be selected to display both breasts simultaneously, showing the radially arranged ducts converging towards the nipple and the glandular tissue in the axillary tail. The 3D thin-slice scan facilitates sagittal and coronal reconstructions. The scan range will cover the superior and inferior borders of both breasts.
Conventional Plain Scan: A SE T1WI sequence will be used to obtain T1-weighted transverse images. Scan parameters: TR 500ms, TE 15ms, slice thickness 2.8mm, FOV for both breasts 360mm, matrix 256x320, NEX 2.
Functional Imaging: A FLASH (Fast Low Angle Shot) sequence will be used for 3D dynamic contrast-enhanced scanning. Scan parameters: TR 4.42ms, TE 1.41ms, flip angle 12 degrees, FOV for both breasts 360mm, matrix 512x384, slice thickness 1.2mm, 6 acquisitions, total time 6 minutes 19 seconds, one acquisition 55 seconds. The contrast agent will be Gd-DTPA at a dose of 0.2 mmol/kg, administered as a bolus injection via an antecubital or dorsal hand vein at a rate of 3 ml/s, followed by a 20 ml saline flush at the same rate. After the first scan, the automatic high-pressure injector will be activated to inject the Gd-DTPA contrast agent and saline. The enhanced scan will be initiated simultaneously with the injection and repeated 5 times. The post-enhancement images will be subtracted from the initial plain scan images to obtain 5 sets of subtracted images. These subtracted images will then be reconstructed using the Maximum Intensity Projection (MIP) method to generate 5 three-dimensional enhanced images.
- Preoperative Implant Size Assessment: The implant volume will be estimated using empirical methods to determine the proposed implant size.
- Surgical Simulation, Design, and 3D Printing of PCL Mesh:
Using medical-grade polycaprolactone (PCL) microspheres as the printing material, the optimized breast mesh model will be manufactured using Selective Laser Sintering (SLS) technology. The model data will be processed by slicing software, and the processed data will be input into the SLS printer. The SLS printer will control the laser scanning path according to the contour and filling structure of the current layer to sinter the PCL powder. This process is repeated layer by layer to print the model structure. After printing, the structure is removed, residual powder on the surface is cleaned off, and the final product is sterilized with low-temperature ethylene oxide for 48 hours before use.
- Surgery:Nipple-sparing subcutaneous mastectomy combined with an implant for immediate breastreconstruction will be performed according to standard clinical practice. The choice of incision will be at the surgeon's discretion. Intraoperatively, tissue from behind the nipple will be sent for frozen section histopathological examination. If the margin is positive, the nipple-areolar complex will be resected following safety principles. The 3D-printed biodegradable biological mesh will be used to wrap the silicone implant, which is then placed in the subcutaneous tissue. The wound will be soaked and irrigated with sterile distilled water and normal saline. After achieving thorough hemostasis, a drain will be placed, and the skin will be closed in layers.
- Postoperative Management:Electronic health records will be established. Follow-ups will be conducted at 1 week, 1 month, 3 months, 6 months, and 12 months post-surgery, and then every 6 months thereafter. Follow-up content includes recording complications or adverse reactions, completing the Chinese version of the BREAST-Q V2.0 scale for breast aesthetics, satisfaction, and QoL assessment, and monitoring for metastasis or recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D printing patient | Experimental | Procedure: Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable meshimmediate breast reconstruction using 3D-Printed Biodegradable Biological Mesh combined with a silicone breast prosthesis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female breast cancer patients aged 18 to 70 years.
- Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines.
- Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast reconstruction.
- ECOG performance status of 0-1.
- Voluntary participation in the study and signing of the written informed consent form.
Key exclusion criteria (8 listed)
- Age >70 years.
- Metastatic breast cancer (Stage IV) at initial diagnosis.
- Multicentric, extensive, diffuse lesions, or inflammatory breast cancer.
- Tumor involvement of the nipple-areolar complex.
- Breast cancer during pregnancy.
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 |
|---|---|---|
| Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable meshNipple-sparing subcutaneous mastectomy combined with an implant for immediate breast reconstruction will be performed according to standard clinical practice. The choice of incision will be at the surgeon's discretion. Intraoperatively, tissue from behind the nipple will be sent for frozen section histopathological examination. If the margin is positive, the nipple-areolar complex will be resected following safety principles. The 3D-printed biodegradable biological mesh will be used to wrap the silicone implant, which is then placed in the subcutaneous tissue. The wound will be soaked and irrigated with sterile distilled water and normal saline. After achieving thorough hemostasis, a drain will be placed, and the skin will be closed in layers. | Procedure or surgery | 3D printing patient |
Primary outcome
postoperative cosmetic results and safety
Time frame: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Postoperative Cosmetic Outcome and Safety: Patient satisfaction will be scored using the reconstruction module of the Breast-Q questionnaire, which includes satisfaction with breasts, satisfaction with surgical outcome, and satisfaction with treatment. Satisfaction with breasts will be the primary endpoint of this study. After the BREAST-Q questionnaire is completed, its score, known as the Q-SCORE, will be calculated. The specific evaluation requires the use of Q-SCORE scoring software. The Breast-Q scale also includes scores for satisfaction with surgery, satisfaction with treatment, and health-related quality of life (QOL), covering physical, psychosocial, and sexual well-being. For all dimensions, a higher patient-reported score indicates higher satisfaction and better quality of life.In outcome of BREAST-Q questionnaire, BREAST-Q scales (domains) are scored on a 0-100 range, with higher scores indicating greater satisfaction or better health-related quality of life.
4 secondary outcomes
Recurrence-Free Survival (RFS)
Time frame: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Disease-Free Survival (DFS)
Time frame: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Overall Survival (OS)
Time frame: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
Surgical Technical Safety (Complication Rate)
Time frame: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 year.
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 26 Jan 2026.
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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?
A study testing Implantation of a silicone breast prosthesis combined with a 3D-printed biodegradable mesh in people with Breast Cancer and Breast Reconstruction After Mastectomy, run by Xijing 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?
The sponsor lists 5 inclusion and 8 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 26 Jan 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?
Contact Ju Liang Zhang, Prof. (029-84775271, vascularzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative cosmetic results and safety (time frame: At 1 week, 1 month, 3 months, 6 months, 12 months ，18 months，and 24 months post-surgery，through study completion, an average of 2 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 26 Jan 2026.