[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"reconstruction-of-the-nipple-areola-complex-in-patients-undergoing-breast-reconstructive-surgery-following-mastectomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:reconstruction-of-the-nipple-areola-complex-in-patients-undergoing-breast-reconstructive-surgery-following-mastectomy":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100613078","biochromaderm-pmcf-study-100613078",false,"NCT07261904","BIOCHROMADERM® PMCF STUDY","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","Inclusion Criteria:\n\n* Female or male ≥18 years old,\n* Requiring the reconstruction of the nipple-areola complex following mastectomy,\n* Affiliated or beneficiary of a social security scheme,\n* Able and willing to provide written informed consent to study participation.\n\nExclusion Criteria:\n\n* Known allergy to pigment ingredients\n* Active, recent or prior history of skin disease, chronic skin disease, history of hypertrophic scars, skin infection or skin inflammatory disease,\n* Patients carrying a prosthesis (especially cardiac),\n* Patients presenting with a coagulation disorder,\n* Patients scheduled for an MRI within 6 months following pigmentation,\n* Patients scheduled for a skin esthetic treatment close to the pigmentation zone (laser, peeling, abrasion, ...) shortly after pigmentation,\n* 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,\n* Pregnant or breastfeeding female,\n* Currently participating to another clinical trial or having participated to a prior clinical trial within 1 month prior to inclusion into the present one,\n* Personal strong objection to medical tattooing,\n* Psychiatric illness\u002Fsocial situations that would limit ability to consent and\u002For to compliance with study requirements,\n* Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.\n\nNote: 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.","ALL","18 Years",{"count":19,"type":20},115,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to:\n\n* To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation;\n* To confirm the continued safety of BIOCHROMADERM®,\n* To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation\n* 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)\n* To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation\n* To assess fading (pigment retention potential) over 12 months\n* To assess the number of pigmentation adjustments needed per patient throughout the study duration\n* To assess patient's satisfaction\u002Fself-confidence evolution post-treatment, both in terms of general breast appearance and as to the specific dermo-pigmentation stage\n* To assess the correlation of the esthetic satisfaction\u002Fself-confidence questionnaire outcomes with those of the Likert Scale and patient satisfaction VAS at 3 months and 12 months post-pigmentation",[24],"Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy","RECRUITING","2025-11-29",{"date":28,"type":29},"2025-12-03","ACTUAL",{"date":31,"type":29},"2025-11-12",{"date":33,"type":20},"2027-06-12",{"name":35,"class":36},"Laboratoires BIOTIC Phocea","INDUSTRY",3]