3D-printed Biodegradable Breast Implants for Breast Restoration
Recruiting
Phase 2
Interventional Study
Breast Cancer
Breast Reconstruction
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 120 (estimated)
- Sponsor
- Xijing Hospital · Other
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About This Trial
The purpose of this clinical trial is to evaluate the cosmetic effect of breast reconstruction based on 3D-printed biodegradable material breast implants in personalized breast reconstruction and the quality of life of patients, with traditional breast-conserving surgery and traditional breast reconstruction as controls. It will also explore the safety of breast reconstruction based on 3D-printed …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female patients with newly diagnosed primary breast cancer, aged 18 to 70 years, confirmed by histopathology.
* Willing to undergo breast-conserving surgery, concurrent silicone prosthesis breast reconstruction, or breast reconstruction with 3D-printed biodegradable material b…
Contacts