Clinical trial · Observational
Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up
NCT05316077CI-TRIAL-00060859unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Vectorio® kit
Primary outcomes (1)
- measure
- Rate of leakage/breakage
- timeFrame
- During cTACE procedure
Secondary outcomes (5)
- measure
- 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).
- timeFrame
- During cTACE procedure
- description
- Collection of the time needed to obtain water in oil emulsion (Lipiodol/chemotherapeutic agent)
- measure
- Ease of emulsion preparation through a rating scale
- timeFrame
- During cTACE procedure
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.