CLARITY Study - PMCF Study

NCT06854263 | Not Yet Recruiting

• 1 other identifier: ID-RCB 2024-A01844-43
• Study Type: observational
• Target: 119
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Mono-arm study

Device: skin marking for radiotherapy treatment

Interventions

skin marking for radiotherapy treatment DEVICE

skin marking for radiotherapy treatment

Mono-arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with cancer requiring skin marking for radiotherapy treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laboratoires BIOTIC Phocea: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 3, 2025
• Study Start: April 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02