Haemostasis EmbolisationNCT06301919
Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization
An observational study of Haemostasis Embolisation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemostasis Embolisation
- What is being tested?
- Clinical data, Imaging data and Biological data
- How many people
- 122 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 1 May 2024
- 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
- Adult, Older adult
Study population: Patients treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.
Who may be able to join
- All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.
Who cannot join
- Patients lost for follow-up, patients without preoperative CT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization : a "Real-life" Retrospective Monocentric Study
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.
- Conditions
- Haemostasis Embolisation
- Being tested
- Clinical data, Imaging data, Biological data
- Keywords
- Emergency, Hemostatic agent, NBCA bleeding, Trans-arterial embolisation
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical dataOther
Collecting data from the medical record.
Imaging dataOther
Collecting data from the medical record.
Biological dataOther
Collecting data from the medical record.
| Study group | Role | What they receive |
|---|---|---|
| Included patients | All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan. Receives: Other: Clinical data; Other: Imaging data; Other: Biological data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of technical success
Analysis of angiographic results.
Measured: Month : 1
Secondary outcomes (5)
Assessment of clinical success
Disappearance of signs and symptoms of bleeding during the 30 days of follow-up after WT
Measured: Month : 1
Assessment of clinical success
No endoscopic treatment
Measured: Month : 1
Assessment of clinical success
No surgical intervention
Measured: Month : 1
Assessment of clinical success
No repeat WT
Measured: Month : 1
Assessment of clinical success
Absence of death due to massive blood loss
Measured: Month : 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemostasis EmbolisationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rémi GRANGE, MD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301919
- Sponsor's protocol ID
- IRBN042024/CHUSTE
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of N-Butyl Cyanoacrylate in Transarterial Emergency Embolization : a "Real-life" Retrospective Monocentric Study
- ClinicalTrials.gov ID
- NCT06301919
- Acronym / sponsor ID
- IRBN042024/CHUSTE
- Conditions
- Haemostasis Embolisation
- Keywords
- Emergency, Hemostatic agent, NBCA bleeding, Trans-arterial embolisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 8 Mar 2024 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Other: Clinical data, Other: Imaging data, Other: Biological dataAll patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.
Key inclusion criteria (1 listed)
- All patients referred to our hospital and treated by TAE with NBCA, based on clinical decisions in emergency and CT scan.
Key exclusion criteria (1 listed)
- Patients lost for follow-up, patients without preoperative CT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical dataCollecting data from the medical record. | Other | Included patients |
| Imaging dataCollecting data from the medical record. | Other | Included patients |
| Biological dataCollecting data from the medical record. | Other | Included patients |
Primary outcome
Evaluation of technical success
Time frame: Month : 1
Analysis of angiographic results.
5 secondary outcomes
Assessment of clinical success
Time frame: Month : 1
Assessment of clinical success
Time frame: Month : 1
Assessment of clinical success
Time frame: Month : 1
Assessment of clinical success
Time frame: Month : 1
Assessment of clinical success
Time frame: Month : 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Haemostasis Embolisation
Not yet recruitingObservational study
HISTOACRYL® Used for Embolization of Thoracoabdominal Artery Bleeding
Hemorrhage, Gastrointestinal Hemorrhage
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.
Rémi GRANGE, MD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Haemostasis Embolisation, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of technical success (time frame: Month : 1). 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 27 Jan 2025.