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

Recruiting

• Conditions: Oncology

• Registration Number: NCT05316077
• Lead Sponsor: Guerbet

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2022-08-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-14
• Last Update Posted: 2022-09-15
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of leakage/breakage	During cTACE procedure

Secondary Outcome Measures

Name	Time	Method
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)
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)
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%
Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)	Study period
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

Trial Locations

Locations (3)

Univ.-Klinik für Radiologie; 🇦🇹 Graz, Austria

CHU-Hôpital François Mitterrand; 🇫🇷 Dijon, France

CHUV; 🇨🇭 Lausanne, Switzerland