Clinical trial · Interventional
Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction
NCT03348293CI-TRIAL-00093044completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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, using porous PCL biomaterials. During operation, the biodegradable scaffold was implanted into the defective cavity after tumor resection. Safety indicator, cosmetic outcome and autologous compatibility were evaluated.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D printing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 3D printing patient
- description
- Immediate breast reconstruction using 3D printing personalized scaffold
- interventionNames
- Procedure: 3D printing
Primary outcomes (1)
- measure
- adverse events
- timeFrame
- 1 year after surgery
- description
- Such adverse events include (but are not limited to) infection, repeated removal of implanted bio-scaffold, the humoral immunological responses.
Secondary outcomes (4)
- measure
- Cosmetic outcome
- timeFrame
- 6 months after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDThe utility of 3D printing for surgical planning and patient-specific implant design for complex spinal pathologies: case report. J Neurosurg Spine. 2017 Apr;26(4):513-518. doi: 10.3171/2016.9.SPINE16371. Epub 2017 Jan 20. PMID 28106524
- RESULTChia HN, Wu BM. Recent advances in 3D printing of biomaterials. J Biol Eng. 2015 Mar 1;9:4. doi: 10.1186/s13036-015-0001-4. eCollection 2015. PMID 25866560
- RESULTIbrahim AM, Jose RR, Rabie AN, Gerstle TL, Lee BT, Lin SJ. Three-dimensional Printing in Developing Countries. Plast Reconstr Surg Glob Open. 2015 Aug 10;3(7):e443. doi: 10.1097/GOX.0000000000000298. eCollection 2015 Jul. PMID 26301132