[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581742":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":10,"centralContacts":10,"locations":10,"responsibleParty":18,"collaborators":10,"id":20,"slug":21,"hasResults":22,"nctId":23,"briefTitle":24,"officialTitle":25,"acronym":10,"eligibilityCriteria":26,"healthyVolunteers":22,"sex":27,"minAge":28,"maxAge":10,"enrollmentInfo":29,"targetDuration":10,"studyType":32,"phases":10,"briefSummary":33,"conditions":34,"keywords":10,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":10},{"fullName":5,"class":6},"Laboratoires BIOTIC Phocea","INDUSTRY",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Mono-arm study",null,[12],"Device: skin marking for radiotherapy treatment",[14],{"type":15,"name":16,"description":16,"armGroupLabels":17,"otherNames":10},"DEVICE","skin marking for radiotherapy treatment",[9],{"type":19,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100581742","clarity-study---pmcf-study-100581742",false,"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.","ALL","18 Years",{"count":30,"type":31},119,"ESTIMATED","OBSERVATIONAL","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.",[35],"Radiation Therapy","NOT_YET_RECRUITING","2025-03-03",{"date":39,"type":40},"2025-03-05","ACTUAL",{"date":42,"type":31},"2025-04",{"date":44,"type":31},"2025-12",{"name":5,"class":6}]