Informations générales (source: ClinicalTrials.gov)
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 (SQUIDperi)
Observational
Centre Hospitalier Universitaire Dijon (Voir sur ClinicalTrials)
avril 2021
mars 2024
29 juin 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Chu Dijon Bourgogne - 21000 - Dijon - France | Romaric LOFFROY | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- 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)