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โ† Trials
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3D-printed Biodegradable Breast Implants for Breast Restoration

RecruitingPhase 2Ages 18 Years - 70 YearsFemaleXijing Hospital
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In plain words

What the trial is, and whether it could suit you

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 reconstruc

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * Age \> 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/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.
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What it tests

  • Breast restoration surgery based on 3D printed degradable biological implants
  • Traditional breast-conserving surgery
  • Traditional silicone prosthesis breast reconstruction
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Where

1 site
Xijing hospital
Xi'an, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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