Arterial BleedSQUIDperiNCT04787120
Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome (SQUIDperi Study)
An observational study of Arterial Bleed and Abdominal, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Abdominopelvic bleeding can occur due to numerous causes including for the vast majority, trauma, surgery complications and tumors. Interventional radiologists often exclude arterial acute hemorrhage using cyanoacrylate or a liquid embolic agent, but few prospective results have been published to assess their efficacy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Bleed, Abdominal, Embolism Arterial
- What is being tested?
- SQUIDperi
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 1 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient requiring an embolization for the treatment of abdominopelvic arterial bleeding or imminent risk of bleeding including visceral, muscular or digestive territories, along with angiographic abnormalities
Who may be able to join
- Patient presenting with an arterial abdominopelvic bleeding or imminent risk of bleeding, including visceral, muscular or GI territories, requiring embolization, along with angiographic abnormalities
- Patient for whom the use of SQUIDperi had been decided for an embolization
- Patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access
- Patient > 18 years
Who cannot join
- Patient with severe live failure
- Patient participating in another interventional study
- Vulnerable patients including pregnant women
- Patient not eligible for treatment with liquid embolic agent
- Patients presenting contra-indications to SQUIDperi as describes in the Informations For Use (IFU)
Trial locations and contacts
1 site in 1 country.
France1 site
Chu Dijon Bourgogne
Dijon, 21000
Romaric LOFFROY, 03 80 29 33 58, romaric.loffroy@chu-dijon.fr
About this study
Official title: A France-based Study for Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome: SQUIDperi Study: A Non-interventional, Prospective, Single-arm, Multicenter Study
Abdominopelvic bleeding can occur due to numerous causes including for the vast majority, trauma, surgery complications and tumors. Interventional radiologists often exclude arterial acute hemorrhage using cyanoacrylate or a liquid embolic agent, but few prospective results have been published to assess their efficacy and safety. The historic and most studied liquid embolic agent to date is Onyx. Results in the treatment of acute peripheral non-neurologic hemorrhage have been detailed in a meta-analysis published in 2015. This systematic review found 19 articles presenting 131 patient cases and 150 lesions treated with Onyx from 2005 to August 2014. There were 11 case series and 8 case reports but no prospective trial. The most common presenting symptoms were of gastrointestinal (GI) origin (n = 51). Rebleeding of the baseline lesion occurred in 7/131 patients. No deaths resulting from complications of the embolic procedure were reported. One patient died of persistent hemoptysis after treatment with Onyx. No deaths were directly attributable to the use of Onyx.
During a peripheral embolization procedure with available embolic agents other than SQUIDPERI, residual feedings or collateral vessels became gradually less visible to the operator due to the high radiopacity of the liquid. It was therefore essential to develop an embolization system with lower radiopacity, or with radiopacity that decreases over time. Additionally, depending on the angioarchitecture and flow characteristics, it is important to have an embolic agent with various viscosities. SQUIDPERI is a liquid embolic agent with various viscosities and radiopacities. It is indicated for the embolization of lesions in the peripheral vasculature but its use is poorly reported as of today.
The purpose of this prospective non interventional multicenter study is to evaluate the safety and efficacy of SQUIDPERI for the treatment of abdominopelvic arterial acute bleeding or imminent risk of bleeding.
- Conditions
- Arterial Bleed, Abdominal, Embolism Arterial, Pelvic Bleeding
- Being tested
- SQUIDperi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SQUIDperiDevice
Liquid embolic delivery syringes and micro-catheter
| Study group | Role | What they receive |
|---|---|---|
| Individuals with arterial abdominopelvic bleeding | Arterial abdominopelvic bleeding or imminent risk of bleeding Receives: Device: SQUIDperi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of embolization success at one month
Defined as the absence of re-intervention for re-bleeding from the target artery/arteries embolized during the index procedure
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial BleedStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787120
- Sponsor's protocol ID
- LOFFROY BALT 2020-1
- Acronym
- SQUIDperi
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Loffroy R, Kobeiter H, Vidal V, Frandon J, Pellerin O, Dean C, Sammoud S, Vernhet-Kovacsik H, Derbel H, Aho-Glele LS, Chevallier O, Sapoval M. Ethylene-vinyl alcohol copolymer-based non-adhesive liquid embolic agent for transcatheter arterial embolization in patients with abdominal/pelvic arterial bleeding: A prospective, single-arm, multicenter cohort study. Diagn Interv Imaging. 2025 Jun;106(6):226-236. doi: 10.1016/j.diii.2025.02.001. Epub 2025 Feb 13.
PubMed 39952827
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A France-based Study for Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome: SQUIDperi Study: A Non-interventional, Prospective, Single-arm, Multicenter Study
- ClinicalTrials.gov ID
- NCT04787120
- Acronym / sponsor ID
- SQUIDperi / LOFFROY BALT 2020-1
- Conditions
- Arterial Bleed, Abdominal, Embolism Arterial, Pelvic Bleeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 8 Mar 2021 (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.
Abdominopelvic bleeding can occur due to numerous causes including for the vast majority, trauma, surgery complications and tumors. Interventional radiologists often exclude arterial acute hemorrhage using cyanoacrylate or a liquid embolic agent, but few prospective results have been published to assess their efficacy and safety. The historic and most studied liquid embolic agent to date is Onyx. Results in the treatment of acute peripheral non-neurologic hemorrhage have been detailed in a meta-analysis published in 2015. This systematic review found 19 articles presenting 131 patient cases and 150 lesions treated with Onyx from 2005 to August 2014. There were 11 case series and 8 case reports but no prospective trial. The most common presenting symptoms were of gastrointestinal (GI) origin (n = 51). Rebleeding of the baseline lesion occurred in 7/131 patients. No deaths resulting from complications of the embolic procedure were reported. One patient died of persistent hemoptysis after treatment with Onyx. No deaths were directly attributable to the use of Onyx.
During a peripheral embolization procedure with available embolic agents other than SQUIDPERI, residual feedings or collateral vessels became gradually less visible to the operator due to the high radiopacity of the liquid. It was therefore essential to develop an embolization system with lower radiopacity, or with radiopacity that decreases over time. Additionally, depending on the angioarchitecture and flow characteristics, it is important to have an embolic agent with various viscosities. SQUIDPERI is a liquid embolic agent with various viscosities and radiopacities. It is indicated for the embolization of lesions in the peripheral vasculature but its use is poorly reported as of today.
The purpose of this prospective non interventional multicenter study is to evaluate the safety and efficacy of SQUIDPERI for the treatment of abdominopelvic arterial acute bleeding or imminent risk of bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with arterial abdominopelvic bleeding | – | Device: SQUIDperiArterial abdominopelvic bleeding or imminent risk of bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient requiring an embolization for the treatment of abdominopelvic arterial bleeding or imminent risk of bleeding including visceral, muscular or digestive territories, along with angiographic abnormalities
Key inclusion criteria (4 listed)
- Patient presenting with an arterial abdominopelvic bleeding or imminent risk of bleeding, including visceral, muscular or GI territories, requiring embolization, along with angiographic abnormalities
- Patient for whom the use of SQUIDperi had been decided for an embolization
- Patient or authorized representative dully informed and having no objection to the clinical data collection and medical file access
- Patient > 18 years
Key exclusion criteria (5 listed)
- Patient with severe live failure
- Patient participating in another interventional study
- Vulnerable patients including pregnant women
- Patient not eligible for treatment with liquid embolic agent
- Patients presenting contra-indications to SQUIDperi as describes in the Informations For Use (IFU)
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 |
|---|---|---|
| SQUIDperiLiquid embolic delivery syringes and micro-catheter | Device | Individuals with arterial abdominopelvic bleeding |
Primary outcome
Assessment of embolization success at one month
Time frame: 1 month
Defined as the absence of re-intervention for re-bleeding from the target artery/arteries embolized during the index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 39952827Loffroy R, Kobeiter H, Vidal V, Frandon J, Pellerin O, Dean C, Sammoud S, Vernhet-Kovacsik H, Derbel H, Aho-Glele LS, Chevallier O, Sapoval M. Ethylene-vinyl alcohol copolymer-based non-adhesive liquid embolic agent for transcatheter arterial embolization in patients with abdominal/pelvic arterial bleeding: A prospective, single-arm, multicenter cohort study. Diagn Interv Imaging. 2025 Jun;106(6):226-236. doi: 10.1016/j.diii.2025.02.001. Epub 2025 Feb 13.
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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.
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 Arterial Bleed and Abdominal, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romaric LOFFROY (03 80 29 33 58, romaric.loffroy@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of embolization success at one month (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787120, which also lists 1 linked publication.
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 8 Mar 2021.