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.
Study Type
OBSERVATIONAL
Enrollment
50
Univ.-Klinik für Radiologie
Graz, Austria
NOT_YET_RECRUITINGCHU-Hôpital François Mitterrand
Dijon, France
RECRUITINGCHUV
Lausanne, Switzerland
NOT_YET_RECRUITINGRate of leakage/breakage
Time frame: 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).
Collection of the time needed to obtain water in oil emulsion (Lipiodol/chemotherapeutic agent)
Time frame: During cTACE procedure
Ease of emulsion preparation through a rating scale
Rating scale: 0: Difficult - 1: Easy - 2: Very Easy (if rating is difficult, reason should be specified)
Time frame: During cTACE procedure
Need to perform remixing during cTACE procedure
Need to perform remixing : Yes/No - If Yes, how many times: Once, twice, three times, more
Time frame: During cTACE procedure
Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT
Lipiodol tumor uptake: 0-25%; 25-50%; 50-75%; 75-100%
Time frame: During cTACE procedure
Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)
Time frame: Study period
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