Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up

Guerbet

Status: Enrolling

Conditions: Oncology

Study type: Observational

Funder types: Industry

Identifiers

NCT05316077

VEC-88-001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Vectorio® kit