Study on the Cosmetic Outcome and Safety Evaluation of 3D Printed Biodegradable Biological Mesh for One-Stage Breast Reconstruction After Radical Mastectomy
Recruiting
N/A
Interventional Study
Breast Cancer
Breast Reconstruction After Mastectomy
3D-Printed Biodegradable Biological Mesh
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 25 (estimated)
- Sponsor
- Xijing Hospital · Other
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About This Trial
Primary objective of this trial: To evaluate the clinical performance (aesthetic outcome and quality of life) and safety of a 3D-printed biodegradable biological mesh in post-mastectomy immediate breast reconstruction. The study targets adult women undergoing total mastectomy for breast cancer followed by implant-based reconstruction. It aims to determine the utility of the 3D-printed biodegradabl…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female breast cancer patients aged 18 to 70 years.
* Histopathologically confirmed invasive breast cancer, as defined by the latest ASCO/NCCN guidelines.
* Unable to undergo breast-conserving surgery or willing to undergo total mastectomy with immediate implant-based breast re…
Contacts