Status:
COMPLETED
Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction
Lead Sponsor:
Xijing Hospital
Conditions:
Breast Reconstruction
Breast Cancer
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
Scope of tumor resection was simulated according to the MR imaging data. After meticulous design, the investigators created the personalized porous biodegradable scaffold and printed by 3D printer, us...
Detailed Description
3D image reconstruction and printing Magnetic model images data were firstly produced by Siemens Trio Tim 3. 0 T MRI. The relative scanning parameters were adjusted as follows: layer thickness 0.9mm; ...
Eligibility Criteria
Inclusion
- Breast cancer patients
- Tumor sized 3 cm to 6 cm
- ECOG score 1-2
- Multiple diffuse lesions in one quadrant
- Written informed consent
Exclusion
- 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
Key Trial Info
Start Date :
July 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03348293
Start Date
July 30 2018
End Date
December 30 2024
Last Update
August 3 2025
Active Locations (1)
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1
Xijing hospital
Xi'an, Shaanxi, China, 710032