NCT06854263尚未招募不适用
ProspeCtive, muLti-site, Single-group, Open-lAbel Study to Evaluate the Safety and Performance of RADSAFE® Inks for radiaTion therapY Site Marking (CLARITY Study)
Laboratoires BIOTIC Phocea0 个研究点目标入组 119 人开始时间: 2025年4月最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 119
- 主要终点
- Evaluate the performance of RADSAFE® for radiation therapy site skin-marking
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluate the performance of RADSAFE® for radiation therapy site skin-marking
时间窗: From enrollment to the end of treatment at 8 weeks
Rate of good or excellent skin marking visibility score (global evaluation) evaluated at the first session of radiotherapy delivery by two radiotherapy manipulators
次要结局
未报告次要终点
研究者
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