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CLARITY Study - PMCF Study 119
Clinical Trial NCT06854263 is an observational study for Radiation Therapy and is currently not yet recruiting. Enrollment is planned to begin on April 1, 2025 and continue until the study accrues 119 participants. Led by Laboratoires BIOTIC Phocea, this study is expected to complete by December 1, 2025. The latest data from ClinicalTrials.gov was last updated on March 5, 2025.
Brief Summary
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.
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)
Conditions
Radiation TherapyOther Study IDs
- ID-RCB 2024-A01844-43
NCT ID Number
Start Date (Actual)
2025-04
Last Update Posted
2025-03-05
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
119
Study Type
Observational
Status
Not yet recruiting
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Mono-arm study | skin marking for radiotherapy treatment skin marking for radiotherapy treatment |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Evaluate the performance of RADSAFE® for radiation therapy site skin-marking | Rate of good or excellent skin marking visibility score (global evaluation) evaluated at the first session of radiotherapy delivery by two radiotherapy manipulators | From enrollment to the end of treatment at 8 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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.
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.
Laboratoires BIOTIC PhoceaNo contact data.