[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Laboratoires BIOTIC Phocea\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"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,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":47,"conditions":48,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":4},"100581742","clarity-study---pmcf-study-100581742","NCT06854263","CLARITY Study - PMCF Study","ProspeCtive, muLti-site, Single-group, Open-lAbel Study to Evaluate the Safety and Performance of RADSAFE® Inks for radiaTion therapY Site Marking (CLARITY Study)","Inclusion Criteria:\n\nMale or female ≥18 years old, Cancer patient requiring radiotherapy, Patient requiring medical tattoo for treatment alignment, Intact skin at site of standard radiotherapy tattoos, ECOG performance status ≤2 (Karnofsky ≥60%), Able to provide written informed consent, Affiliated patient or beneficiary of a social security scheme.\n\nExclusion Criteria:\n\nPrevious medical tattoo of the targeted zone of treatment Known allergy to pigment ingredients, Infected or diseased skin, past or present, Affected organs close to the skin (eyes), Hypertrophic scars at site of radiotherapy tattoos, Carrying cardiac implant, Patient with blood clotting disorders, No consent to study participation, Under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision, An existing medical condition that, in the opinion of the Investigator, may put the subject at risk or compromise their participation in the study, Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements, Females who are pregnant, lactating, or unwilling to use adequate birth control for the duration of the study, Personal objection to medical tattooing, Participation to another drug or medical device clinical interventional study that may interfere with the clinical investigation objectives.",{"count":46,"type":20},119,"In the context of the Post-Market Clinical Follow-up (PMCF), this study aimed at evaluating the safety and performance of the RADSAFE® inks in the marking of the radiation field.",[49],"Radiation Therapy","NOT_YET_RECRUITING","2025-03-03",{"date":53,"type":29},"2025-03-05",{"date":55,"type":20},"2025-04",{"date":57,"type":20},"2025-12",{"name":35,"class":36},""]