BIOCHROMADERM® PMCF STUDY
Recruiting
Observational Study
Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 115 (estimated)
- Sponsor
- Laboratoires BIOTIC Phocea · Industry
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About This Trial
The goal of this observational study is to:
* To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation;
* To confirm the continued safety of BIOCHROMADERM®,
* To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation
* To assess the long-term performance o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Female or male ≥18 years old,
* Requiring the reconstruction of the nipple-areola complex following mastectomy,
* Affiliated or beneficiary of a social security scheme,
* Able and willing to provide written informed consent to study participation.
Exclusion Criteria:
* Known…
Contacts