Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT07261904
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 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07261904
Study Brief:
Protocol Section:
NCT07261904