CLARITY Study - PMCF Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: skin marking for radiotherapy treatment.
- Who it may be relevant to
- Registry conditions: Radiation Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
ProspeCtive, muLti-site, Single-group, Open-lAbel Study to Evaluate the Safety and Performance of RADSAFE® Inks for radiaTion therapY Site Marking (CLARITY Study)
Overview
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.
Interventions
- Device skin marking for radiotherapy treatment
skin marking for radiotherapy treatment
Primary outcome measures
- Evaluate the performance of RADSAFE® for radiation therapy site skin-marking [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
Inclusion criteria
Male 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.
Exclusion criteria
Previous 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/social 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06854263 · ID-RCB 2024-A01844-43