NCT05316077招募中不适用
Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Guerbet
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Rate of leakage/breakage
研究概览
简要总结
This study is conducted within the frame of the Post-Market Surveillance (PMS) activities, as described in the Post Market Clinical Follow-up (PMCF) plan of Vectorio®. This study aims at collecting clinical data, to confirm the General Safety and Performance Requirements of Vectorio® which is a Lipiodol Resistant Mixing & Injection System for cTACE.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Female or male adult patient older than 18 years
- •Patient with confirmed diagnosis of HCC and eligible for cTACE procedure
- •Patient affiliated to national health insurance according to local regulatory requirements
- •Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent form
排除标准
- •Patient with contraindications to cTACE procedure
- •Patient with known contra-indication(s) to the use or with known sensitivity to Lipiodol or chemotherapeutic agent
- •Pregnant or breast-feeding female patient.
- •Patient unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study
结局指标
主要结局
Rate of leakage/breakage
时间窗: During cTACE procedure
次要结局
- Ease of emulsion preparation through a rating scale(During cTACE procedure)
- Time necessary to obtain a water in oil emulsion defined as time between the filling of 20 mL-syringe with Lipiodol (T0) and the obtention of water in oil emulsion ready for injection (Te).(During cTACE procedure)
- Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT(During cTACE procedure)
- Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)(Study period)
- Need to perform remixing during cTACE procedure(During cTACE procedure)
研究者
研究点 (3)
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