NCT06301919

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

January 27, 2025

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 4, 2024

Last Update Submit

January 24, 2025

Conditions

Haemostasis Embolisation

Keywords

EmergencyHemostatic agentNBCA bleedingTrans-arterial embolisation

Outcome Measures

Primary Outcomes (1)

  • Evaluation of technical success

    Analysis of angiographic results.

    Month : 1

Secondary Outcomes (5)

  • Assessment of clinical success

    Month : 1

  • Assessment of clinical success

    Month : 1

  • Assessment of clinical success

    Month : 1

  • Assessment of clinical success

    Month : 1

  • Assessment of clinical success

    Month : 1

Study Arms (1)

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 dataOther: Imaging dataOther: Biological data

Interventions

Clinical dataOTHER

Collecting data from the medical record.

Included patients
Imaging dataOTHER

Collecting data from the medical record.

Included patients
Biological dataOTHER

Collecting data from the medical record.

Included patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Priest-en-Jarez, 42270, France

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rémi GRANGE, MD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 8, 2024

Study Start

March 1, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

January 27, 2025

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)