[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613078":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":7,"centralContacts":8,"locations":14,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":7,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":7,"enrollmentInfo":68,"targetDuration":7,"studyType":71,"phases":7,"briefSummary":72,"conditions":73,"keywords":7,"overallStatus":33,"whyStopped":7,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Laboratoires BIOTIC Phocea","INDUSTRY",null,[9],{"name":10,"role":11,"phone":12,"phoneExt":7,"email":13},"Marie-Hélène BACHELEY","CONTACT","+33785453676","regulatory@biotic.fr",[15,31,43],{"facility":16,"status":17,"city":18,"state":7,"zip":7,"country":19,"countryCode":20,"cosmosGeoPoint":21,"geoPoint":26,"contacts":27},"Centre Oscar Lambret","NOT_YET_RECRUITING","Lille","France","FR",{"type":22,"coordinates":23},"Point",[24,25],3.05512,50.63391,{"lat":25,"lon":24},[28],{"name":29,"role":30,"phone":7,"phoneExt":7,"email":7},"Claudia Regis, Doctor","PRINCIPAL_INVESTIGATOR",{"facility":32,"status":33,"city":34,"state":7,"zip":7,"country":19,"countryCode":20,"cosmosGeoPoint":35,"geoPoint":39,"contacts":40},"Hôpital de La Conception","RECRUITING","Marseille",{"type":22,"coordinates":36},[37,38],5.38107,43.29695,{"lat":38,"lon":37},[41],{"name":42,"role":30,"phone":7,"phoneExt":7,"email":7},"Dominique Casanova, Professor",{"facility":44,"status":17,"city":45,"state":7,"zip":7,"country":19,"countryCode":20,"cosmosGeoPoint":46,"geoPoint":50,"contacts":51},"Institut de Cancérologie de Lorraine","Vandœuvre-lès-Nancy",{"type":22,"coordinates":47},[48,49],6.17114,48.66115,{"lat":49,"lon":48},[52],{"name":53,"role":30,"phone":7,"phoneExt":7,"email":7},"Laetitia Goffinet, Doctor",{"type":55,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR",[57],{"name":58,"class":6},"Clinical Research Consultants, Inc.","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":69,"type":70},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",[74],"Reconstruction of the Nipple-areola Complex in Patients Undergoing Breast Reconstructive Surgery Following Mastectomy","2025-11-29",{"date":77,"type":78},"2025-12-03","ACTUAL",{"date":80,"type":78},"2025-11-12",{"date":82,"type":70},"2027-06-12",{"name":5,"class":6},3]