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

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05316077
• Other study ID #: VEC-88-001
• Status: Recruiting
• Start date: August 30, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: September 2022
• Source: Guerbet
• Contact: Jing Hao
• Phone: +33 6 47 12 19 57
• Email: jing.hao[@]guerbet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Locations

Country	Name	City	State
Austria	Univ.-Klinik für Radiologie	Graz
France	CHU-Hôpital François Mitterrand	Dijon
Switzerland	CHUV	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Guerbet

Countries where clinical trial is conducted

Austria,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of leakage/breakage		During cTACE procedure
Secondary	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).	Collection of the time needed to obtain water in oil emulsion (Lipiodol/chemotherapeutic agent)	During cTACE procedure
Secondary	Ease of emulsion preparation through a rating scale	Rating scale: 0: Difficult - 1: Easy - 2: Very Easy (if rating is difficult, reason should be specified)	During cTACE procedure
Secondary	Need to perform remixing during cTACE procedure	Need to perform remixing : Yes/No - If Yes, how many times: Once, twice, three times, more	During cTACE procedure
Secondary	Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT	Lipiodol tumor uptake: 0-25%; 25-50%; 50-75%; 75-100%	During cTACE procedure
Secondary	Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)		Study period