Safety and Performance of Optivantage Multi-use When Inje... | NCT05537779

Studies
Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination

NCT05537779

Sponsor

Guerbet

Status

Unknown status

Last Update Posted

Sep 13, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Patient Participation

Interventions

CT examination

Countries

Not provided

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

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2022Estimated

Primary Completion Date

Dec 2022Estimated

Completion Date

Jan 2023Estimated

First Submitted Date

Sep 8, 2022

First Submission Date that Met QC Criteria

Sep 8, 2022

First Posted Date

Sep 13, 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 8, 2022

Last Update Posted Date

Sep 13, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

The study is a prospective, single-arm observational multicenter clinical investigation.

The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.

Detailed Description

Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System.

100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.

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

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CT examination	Device	Administration of contrast medium using the power injector

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of Optivantage	Rate of extravasation	Per procedure
Performance of Optivantage	Success of injection	Per procedure

Secondary Outcomes

Measure	Description	Time Frame
Safety of Optivantage	Rate of patient complications	Per procedure
Device deficiencies	Rate of device deficiencies including malfunction and error use

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject referred for a contrast-enhanced CT examination using a power injector
Subject or legal representative for children, having provided written informed consent

Exclusion Criteria:

Subject weighting less than 10 kg
Pregnant or breastfeading woman subject
Subject with known allergy or hypersensitivity to contrast media
Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics
Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection
Subject 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

2 Years

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Subjects referred for contrast enhanced CT examination who meet the eligibility criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jing Hao, MD	Contact	+33 (0)1 45 91 51 76		jing.hao@guerbet.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010358	Patient Participation

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided