[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613078":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":11,"studyPopulation":34,"armGroups":11,"interventions":11,"overallOfficials":11,"centralContacts":35,"locations":41,"responsibleParty":81,"collaborators":83,"id":86,"slug":11,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":11,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":11,"enrollmentInfo":94,"targetDuration":11,"studyType":97,"phases":11,"briefSummary":98,"conditions":99,"keywords":11,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Laboratoires BIOTIC Phocea","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"To confirm the continued performance of BIOCHROMADERM® in restoring a near-normal pigmentary appearance of the nipple-areola complex at 3 months post-pigmentation",null,"3 months post-pigmentation",[14,17,19,21,23,25,27,29],{"measure":15,"description":11,"timeFrame":16},"To confirm the continued safety of BIOCHROMADERM®","12 months",{"measure":18,"description":11,"timeFrame":16},"To confirm adequate usability and describe the optimal process for BIOCHROMADERM® implantation",{"measure":20,"description":11,"timeFrame":16},"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)",{"measure":22,"description":11,"timeFrame":16},"To assess the evolution of performance (Likert scale) between baseline, 3 months and 12 months post-pigmentation",{"measure":24,"description":11,"timeFrame":16},"To assess fading (pigment retention potential) over 12 months",{"measure":26,"description":11,"timeFrame":16},"To assess the number of pigmentation adjustments needed per patient throughout the study duration",{"measure":28,"description":11,"timeFrame":16},"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",{"measure":30,"description":11,"timeFrame":16},"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",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":32,"timePerspective":33,"maskingInfo":11},"OTHER","PROSPECTIVE","Adult patients requiring the correction of skin pigmentation in the NAC area as a result of breast reconstructive surgery following mastectomy.\n\nUp to 115 patients will be included into the study by 3 clinical sites, in order to obtain 103 treated patients followed up over 12 months post-procedure per protocol",[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Marie-Hélène BACHELEY","CONTACT","+33785453676","regulatory@biotic.fr",[42,58,70],{"facility":43,"status":44,"city":45,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Centre Oscar Lambret","NOT_YET_RECRUITING","Lille","France","FR",{"type":49,"coordinates":50},"Point",[51,52],3.05512,50.63391,{"lat":52,"lon":51},[55],{"name":56,"role":57,"phone":11,"phoneExt":11,"email":11},"Claudia Regis, Doctor","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":60,"city":61,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Hôpital de La Conception","RECRUITING","Marseille",{"type":49,"coordinates":63},[64,65],5.38107,43.29695,{"lat":65,"lon":64},[68],{"name":69,"role":57,"phone":11,"phoneExt":11,"email":11},"Dominique Casanova, Professor",{"facility":71,"status":44,"city":72,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Institut de Cancérologie de Lorraine","Vandœuvre-lès-Nancy",{"type":49,"coordinates":74},[75,76],6.17114,48.66115,{"lat":76,"lon":75},[79],{"name":80,"role":57,"phone":11,"phoneExt":11,"email":11},"Laetitia Goffinet, Doctor",{"type":82,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[84],{"name":85,"class":6},"Clinical Research Consultants, Inc.","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":95,"type":96},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",[100],"Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy","2025-11-29",{"date":103,"type":104},"2025-12-03","ACTUAL",{"date":106,"type":104},"2025-11-12",{"date":108,"type":96},"2027-06-12",{"name":5,"class":6},3]