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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pelvic Bleeding; Arterial Bleed; Abdominal; Embolism Arterial
• Intervention / Treatment: Device: SQUIDperi

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

• Study Contact: Name: Romaric LOFFROY; Phone Number: 03 80 29 33 58; Email: romaric.loffroy@chu-dijon.fr

Study Locations

• France
  • Dijon, France, 21000
    • CHU Dijon Bourgogne
    • Contact: Romaric LOFFROY; Phone Number: 03 80 29 33 58; Email: romaric.loffroy@chu-dijon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with arterial abdominopelvic bleeding; Arterial abdominopelvic bleeding or imminent risk of bleeding	Device: SQUIDperi; Liquid embolic delivery syringes and micro-catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 month

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 5, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Embolism; Hemorrhage
• Other Study ID Numbers: LOFFROY BALT 2020-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No