Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787120
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2021-03-03
Brief Title:
Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome SQUIDperi Study
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SQUIDperi
Brief 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 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 7131 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None