BIOCHROMADERM® PMCF STUDY

Официальное название

Prospective, Observational, Multicentre, Single Group, Open-label Study to Confirm the Safety and Effectiveness of BIOCHROMADERM® Ink for the Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy

Обзор

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

Первичные конечные точки

• To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation [Срок оценки: 3 months post-pigmentation]

Вторичные конечные точки (8)

• To confirm the continued safety of BIOCHROMADERM® [Срок оценки: 12 months]
• To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation [Срок оценки: 12 months]
• 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) [Срок оценки: 12 months]
• To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation [Срок оценки: 12 months]
• To assess fading (pigment retention potential) over 12 months [Срок оценки: 12 months]
• To assess the number of pigmentation adjustments needed per patient throughout the study duration [Срок оценки: 12 months]
• 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 [Срок оценки: 12 months]
• 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 [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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,
• Patients scheduled for an MRI within 6 months following pigmentation,
• Patients scheduled for a skin esthetic treatment close to the pigmentation zone (laser, peeling, abrasion, ...) shortly after pigmentation,
• Existing medical condition or organ pathology close to the skin that the Investigator considers may put the patient at risk or compromise their participation in the study,
• Pregnant or breastfeeding female,
• Currently participating to another clinical trial or having participated to a prior clinical trial within 1 month prior to inclusion into the present one,
• Personal strong objection to medical tattooing,
• Psychiatric illness/social situations that would limit ability to consent and/or to compliance with study requirements,
• Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.

Note: The recent use of permanent wrinkle or lip filling products close to the scheduled pigmentation zone (silicon, PTFE, ...) is a contraindication in the approved product IFU but is not relevant to the breast reconstruction indication.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 3 центра

• Centre Oscar Lambret — Lille
• Hôpital de La Conception — Marseille
• Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy

Идентификаторы

NCT: NCT07261904 · ID-RCB 2024-A01845-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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