Personalized biodegradable implants for breast reconstruction
Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction
PHASE1 · Xijing Hospital · NCT03348293
This study is testing if 3D printed biodegradable implants can safely help women who have had breast cancer surgery by providing temporary support for healing.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Xijing Hospital (other) |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT03348293 on ClinicalTrials.gov |
What this trial studies
This study focuses on the safety of using 3D printed personalized biodegradable implants for breast reconstruction in patients undergoing tumor resection due to breast cancer. The approach involves creating a porous scaffold tailored to the patient's specific tumor size and shape using advanced imaging techniques and 3D printing technology. The biodegradable scaffold is implanted into the cavity left after tumor removal, and the study evaluates safety, cosmetic outcomes, and compatibility with the patient's body. The use of biodegradable materials aims to provide a temporary support structure that degrades over time, promoting natural healing.
Who should consider this trial
Good fit: Ideal candidates for this study are breast cancer patients with tumors sized between 3 cm and 6 cm and an ECOG performance status of 1-2.
Not a fit: Patients with triple negative breast cancer, inflammatory breast carcinoma, or those with serious operative contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance breast reconstruction outcomes and improve the quality of life for breast cancer patients.
How similar studies have performed: While the use of 3D printing in medical applications is gaining traction, this specific approach to biodegradable implants for breast reconstruction is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Breast cancer patients * Tumor sized 3 cm to 6 cm * ECOG score 1-2 * Multiple diffuse lesions in one quadrant * Written informed consent Exclusion Criteria: * Triple negative breast cancer patients * Participant in another clinical study * Pregnancy and breastfeeding * Patients with nipple infringement * Inflammatory breast carcinoma * Paget's disease * Serious operative contraindication * Contraindication for MRI
Where this trial is running
Xi'an, Shaanxi
- Xijing hospital — Xi'an, Shaanxi, China (RECRUITING)
Study contacts
- Study coordinator: Ju liang Zhang, Prof.
- Email: vascularzhang@163.com
- Phone: 029-84775271
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Reconstruction, Breast Cancer, biodegradable scaffold, immediate breast reconstruction, 3D printing