CompletedPhase 1

Safety Study of 3D Printing Personalized Biodegradable Implant for Breast Reconstruction

China30 participantsStarted 2018-07-30

Plain-language 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, 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.

Who can participate

Age range18 Years – 60 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

adverse events

Timeframe: 1 year after surgery

Trial details

NCT IDNCT03348293

SponsorXijing Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-30

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