Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT07261904
Brief Summary:
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
Study:
NCT07261904
Study Brief:
Protocol Section:
NCT07261904