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.
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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

Marie-Hélène BACHELEY

+33785453676

regulatory@biotic.fr

CONTACT