Oncology
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Guerbet
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female or male adult patient older than 18 years 2. Patient with confirmed diagnosis of HCC and eligible for cTACE procedure 3. Patient affiliated to national health insurance according to local regulatory requirements 4. Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent form
Exclusion criteria
1. Patient with contraindications to cTACE procedure 2. Patient with known contra-indication(s) to the use or with known sensitivity to Lipiodol or chemotherapeutic agent 3. Pregnant or breast-feeding female patient. 4. Patient unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of leakage/breakage | During cTACE procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs) | Study period | — |
| Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT | During cTACE procedure | Lipiodol tumor uptake: 0-25%; 25-50%; 50-75%; 75-100% |
| 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 | Collection of the time needed to obtain water in oil emulsion (Lipiodol/chemotherapeutic agent) |
| Ease of emulsion preparation through a rating scale | During cTACE procedure | Rating scale: 0: Difficult - 1: Easy - 2: Very Easy (if rating is difficult, reason should be specified) |
| Need to perform remixing during cTACE procedure | During cTACE procedure | Need to perform remixing : Yes/No - If Yes, how many times: Once, twice, three times, more |
Countries
Austria, France, Switzerland
Contacts
Primary ContactJing Hao
Outcome results
None listed