OncologyNCT05316077
Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up
An observational study of Oncology, run by Guerbet at 3 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology
- How many people
- 50 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 30 Aug 2022to 31 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with confirmed diagnosis of hepatocellular carcinoma (HCC) and eligible for cTACE procedures
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Austria1 site, 1 recruiting
- Not yet recruiting
Univ.-Klinik für Radiologie
Graz
Rupert Portugaller, Dr
France1 site, 1 recruiting
- Recruiting
CHU-Hôpital François Mitterrand
Dijon
Romaric Loffroy, Pr
Switzerland1 site, 1 recruiting
- Not yet recruiting
CHUV
Lausanne
Rafael Duran, Dr
About this study
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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vectorio® kit | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of leakage/breakage
Measured: 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).
Collection of the time needed to obtain water in oil emulsion (Lipiodol/chemotherapeutic agent)
Measured: During cTACE procedure
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)
Measured: During cTACE procedure
Need to perform remixing during cTACE procedure
Need to perform remixing : Yes/No - If Yes, how many times: Once, twice, three times, more
Measured: During cTACE procedure
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%
Measured: During cTACE procedure
Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)
Measured: Study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start30 Aug 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316077
- Sponsor's protocol ID
- VEC-88-001
- Status last verified
- Sep 2022
- First submitted
- 18 Mar 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of Vectorio® in Conventional Trans-Arterial Chemo-Embolization (cTACE): A Post-Market Clinical Follow-up
- ClinicalTrials.gov ID
- NCT05316077
- Acronym / sponsor ID
- VEC-88-001
- Conditions
- Oncology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vectorio® kit | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with confirmed diagnosis of hepatocellular carcinoma (HCC) and eligible for cTACE procedures
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of leakage/breakage
Time frame: During cTACE procedure
5 secondary outcomes
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
Ease of emulsion preparation through a rating scale
Time frame: During cTACE procedure
Need to perform remixing during cTACE procedure
Time frame: During cTACE procedure
Assessment of per procedure Lipiodol tumor uptake rate by angiography and/or Cone Beam CT
Time frame: During cTACE procedure
Collection of Adverse Device Effects (ADEs)/Serious Adverse Device Effects (SADEs) /Device Deficiencies (DDs)
Time frame: Study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology, run by Guerbet at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, France, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Hao (+33 6 47 12 19 57, jing.hao@guerbet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of leakage/breakage (time frame: During cTACE procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.