Safety and Performance of Vectorio® in Conventional Trans... | NCT05316077

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

NCT05316077

Sponsor

Guerbet

Status

Unknown status

Last Update Posted

Sep 15, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Oncology

Interventions

Not provided

Countries

Austria
France
Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2022Actual

Primary Completion Date

Mar 31, 2023Estimated

Completion Date

Mar 31, 2023Estimated

First Submitted Date

Mar 18, 2022

First Submission Date that Met QC Criteria

Mar 30, 2022

First Posted Date

Apr 7, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2022

Last Update Posted Date

Sep 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Label	Type	Description	Intervention Names
Vectorio® kit

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of leakage/breakage		During cTACE procedure

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jing Hao	Contact	+33 6 47 12 19 57		jing.hao@guerbet.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univ.-Klinik für Radiologie	Not yet recruiting	Graz			Austria

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided