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

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT05316077

Studienbeginn:
August 2022

Letztes Update:
15.09.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Guerbet

Collaborator:
-

Kontakt

Jing Hao
Kontakt:
Phone: +33 6 47 12 19 57
E-Mail: jing.hao@guerbet.com» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

Univ.-Klinik für Radiologie
Graz
AustriaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Rupert Portugaller, Dr» Ansprechpartner anzeigen

CHU-Hôpital François Mitterrand
Dijon
FranceRekrutierend» Google-Maps
Ansprechpartner:
Romaric Loffroy, Pr» Ansprechpartner anzeigen

CHUV
Lausanne
SwitzerlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Rafael Duran, Dr» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Rate of leakage/breakage (Time Frame - During cTACE procedure)

Secondary outcome:

1. 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). (Time Frame - During cTACE procedure):
Collection of the time needed to obtain water in oil emulsion (Lipiodol/chemotherapeutic agent)

2. Ease of emulsion preparation through a rating scale (Time Frame - During cTACE procedure):
Rating scale: 0: Difficult - 1: Easy - 2: Very Easy (if rating is difficult, reason should be specified)

3. Need to perform remixing during cTACE procedure (Time Frame - During cTACE procedure):
Need to perform remixing : Yes/No - If Yes, how many times: Once, twice, three times, more

4. Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT (Time Frame - During cTACE procedure):
Lipiodol tumor uptake: 0-25%; 25-50%; 50-75%; 75-100%

5. Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs) (Time Frame - Study period)

Quelle: ClinicalTrials.gov

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

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