Use of N-Butyl Cyanoacrylate in Transarterial Emergency E... | NCT06301919

Studies
Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization

NCT06301919

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Last Update Posted

Jan 27, 2025Actual

Enrollment

122Actual

Phase

Not provided

Conditions

Haemostasis Embolisation

Interventions

Clinical data
Imaging data
Biological data

Countries

France

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2024Actual

Primary Completion Date

May 1, 2024Actual

Completion Date

May 1, 2024Actual

First Submitted Date

Mar 4, 2024

First Submission Date that Met QC Criteria

Mar 4, 2024

First Posted Date

Mar 8, 2024Actual

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

Jan 24, 2025

Last Update Posted Date

Jan 27, 2025Actual

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

NBCA is a synthetic biodegradable cyanoacrylate basis glue, modified by the addition of a monomer with adhesive, hemostatic, and antiseptic properties.

Its use requires a steep learning curve to control emulsification of the NBCA/lipiodol mixture, and injection, to avoid non-target embolization.

The aim of this retrospective monocentric study was to evaluate safety and efficacy of use of NBCA as embolic agent in emergency setting.

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

122Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Included patients		All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.	Other: Clinical data Other: Imaging data Other: Biological data

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clinical data	Other	Collecting data from the medical record.	Included patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of technical success	Analysis of angiographic results.	Month : 1

Secondary Outcomes

Measure	Description	Time Frame
Assessment of clinical success	Disappearance of signs and symptoms of bleeding during the 30 days of follow-up after WT	Month : 1
Assessment of clinical success	No endoscopic treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.

Exclusion Criteria:

Patients lost for follow-up, patients without preoperative CT.

Accepts Healthy Volunteers

Not provided

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

Patients treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rémi GRANGE, MD	CHU de Saint-Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Saint-Etienne		Saint-Priest-en-Jarez		42270	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004630	Emergencies

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided