NCT04787120: SQUIDperi

Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome (SQUIDperi Study)

Status unknown Last updated 8 March 2021

What this trial tests

trial testing SQUIDperi in Arterial Bleed in 110 participants. Status unknown.

Timeline

1 April 2021

Primary endpoint
1 October 2023

1 March 2024

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	110
Start date	1 April 2021
Primary completion	1 October 2023
Estimated completion	1 March 2024
Sites	1 location across France

Drugs / interventions tested

• SQUIDperi

Conditions studied

• Arterial Bleed — all drugs for Arterial Bleed →
• Abdominal — all drugs for Abdominal →
• Embolism Arterial — all drugs for Embolism Arterial →
• Pelvic Bleeding — all drugs for Pelvic Bleeding →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

18 and older, any sex, with Arterial Bleed or Abdominal. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Loffroy R, Kobeiter H, Vidal V, Frandon J, et al · · 2025 · cited 3× · PMID 39952827 · DOI 10.1016/j.diii.2025.02.001