Safety and performance of a Lipiodol-resistant mixing and injection system in conventional trans-arterial chemoembolization: A post-market clinical follow-up.

OBJECTIVE

To confirm the safety and performance of Vectorio®, a Lipiodol-resistant mixing and injection system for conventional trans-arterial chemoembolization (cTACE) in clinical practice.

MATERIALS AND

METHODS

This was a prospective, observational, single-arm, multicenter post-market clinical follow-up study conducted between August 2022 and May 2023 (NCT05316077). Adult patients with confirmed hepatocellular carcinoma (HCC) and eligible for cTACE were considered for enrollment. The leakage/breakage rate and the technical performance of Vectorio®, assessed as the ease of use, were evaluated. Adverse events (AE) and device deficiencies were collected up to 24 h after the procedure.

RESULTS

The study included 50 patients (76.0 % male; mean ± SD age: 69.1 ± 9.6 years) with intermediate-stage HCC. One case of leakage, resulting from a user error, was reported. The resulting leakage/breakage rate of Vectorio® was 2.0 % (1/50; 95 %CI: [0.4---10.5]). The usability of the device was evaluated as 'easy' or 'very easy' for all the assessed characteristics except for three procedures (6.0 %) during which the disconnection of the syringes from the stopcock, was deemed to be difficult. A total of 7 AEs of mild or moderate intensity were observed in 6 patients. None were related to the device, and none were serious. Study limitations include: small sample size, absence of comparator, and short-follow up period.

CONCLUSIONS

This study supports the safety and performance of Vectorio® for the mixing and injection of the Lipiodol/chemotherapeutic agent emulsion for cTACE.