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

NCT05316077 | Unknown

• 1 other identifier: VEC-88-001
• Study Type: observational
• Target: 50
• Locations: 3 countries
• Sites: 3

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.

Conditions

Oncology

Outcome Measures

Primary Outcomes (1)

• Rate of leakage/breakage

  During cTACE procedure

Secondary Outcomes (5)

• 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

• Ease of emulsion preparation through a rating scale

  During cTACE procedure

• Need to perform remixing during cTACE procedure

  During cTACE procedure

• Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT

  During cTACE procedure

• Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)

  Study period

Study Arms (1)

Vectorio® kit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with confirmed diagnosis of hepatocellular carcinoma (HCC) and eligible for cTACE procedures

You may qualify if:

• Female or male adult patient older than 18 years
• Patient with confirmed diagnosis of HCC and eligible for cTACE procedure
• Patient affiliated to national health insurance according to local regulatory requirements
• Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent form

You may not qualify if:

• Patient with contraindications to cTACE procedure
• Patient with known contra-indication(s) to the use or with known sensitivity to Lipiodol or chemotherapeutic agent
• Pregnant or breast-feeding female patient.
• Patient unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study

Sponsors & Collaborators

• Guerbet: lead

Study Sites (3)

Univ.-Klinik für Radiologie

Graz, Austria

NOT YET RECRUITING

CHU-Hôpital François Mitterrand

Dijon, France

RECRUITING

CHUV

Lausanne, Switzerland

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Jing Hao

CONTACT

+33 6 47 12 19 57; jing.hao@guerbet.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 7, 2022
• Study Start: August 30, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

AU (1); CH (1); FR (1)