Actively Recruiting
3D-printed Biodegradable Breast Implants for Breast Restoration
Led by Xijing Hospital · Updated on 2025-06-06
120
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction. The main question it aims to answer is: Can breast cancer patients who are not suitable for breast-conserving surgery use 3D-printed biodegradable material breast implants for breast reconstruction? Do patients who undergo breast reconstruction based on 3D-printed biodegradable material breast implants have advantages over those who receive breast-conserving surgery or traditional silicone prosthesis breast reconstruction surgery in terms of cosmetic effects, quality of life and safety? What medical problems may occur when participants use 3D-printed biodegradable material-based breast implants for breast reconstruction? Participants will: Non-random enrollment. In the experimental group, breast reduction surgery based on 3D-printed degradable biological implants was received; In control group 1, traditional breast-conserving surgery was received; Traditional silicone prosthesis breast reconstruction was received in control Group 2.
CONDITIONS
Official Title
3D-printed Biodegradable Breast Implants for Breast Restoration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.
- Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material breast implants.
- Having indications for subcutaneous glandectomy that preserves the nipples and areolas.
- ECOG performance status score: 0-1.
- If receiving neoadjuvant chemotherapy, the interval between chemotherapy completion and surgery is less than 8 weeks.
- Good compliance with the planned treatment, ability to understand the study procedures, and willingness to sign the written informed consent form.
You will not qualify if you...
- Age over 70 years.
- Newly diagnosed stage IV metastatic breast cancer.
- Multicentric, extensive, or diffuse lesions; or inflammatory breast cancer.
- Tumor invasion of the papillary areola complex.
- Inability to accept or tolerate radiotherapy.
- Breast cancer during pregnancy.
- History of other malignant tumors within the past five years (except cured cervical carcinoma in situ and non-melanoma skin cancer).
- Abnormal functions of vital organs (heart, lungs, liver, kidneys), poorly controlled diabetes, or other conditions that preclude surgery tolerance.
- Patients deemed unsuitable for participation by the researchers.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
J
Ju liang J L Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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