CLARITY Study - PMCF Study
ConditionRadiation Therapy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLaboratoires BIOTIC Phocea
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Adult patients with cancer requiring skin marking for radiotherapy treatment
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
skin marking for radiotherapy treatment
Deviceskin marking for radiotherapy treatment
Treatment groups
119 Participants
are divided into 1 treatment groupGroup A: Mono-arm study1 intervention
Trial outcomes
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
Time frame
From enrollment to the end of treatment at 8 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: