BIOCHROMADERM® PMCF STUDY
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaboratoires BIOTIC Phocea
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 of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 12 months post-pigmentation (Likert scale) * To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation * To assess fading (pigment retention potential) over 12 months * To assess the number of pigmentation adjustments needed per patient throughout the study duration * To assess patient's satisfaction/self-confidence evolution post-treatment, both in terms of general breast appearance and as to the specific dermo-pigmentation stage * To assess the correlation of the esthetic satisfaction/self-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation
Eligibility criteria
Qualifiers
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.
Disqualifiers
Known allergy to pigment ingredients
Active, recent or prior history of skin disease, chronic skin disease, history of hypertrophic scars, skin infection or skin inflammatory disease,
Patients carrying a prosthesis (especially cardiac),
Patients presenting with a coagulation disorder,
Trial design
Treatments tested in this trial
- Not listed
Trial groups
No trial groups listed
Sponsors and collaborators
Laboratoires BIOTIC Phocea
Lead sponsor
Clinical Research Consultants, Inc.
Collaborator
Source ClinicalTrials.gov