Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456125
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-04
Brief Title:
Safety and Efficacy Of Amber Peripheral Liquid Embolic System
Sponsor:
LVD Biotech SL
Organization:
LVD Biotech SL
Study Overview
Official Title:
Safety and Efficacy Of Amber Peripheral Liquid Embolic System a First-in-HumAn PivotaL Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
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:
OPAL
Brief Summary:
A prospective single-arm multicenter open-label First-in-Human Pivotal Study to assess the safety and efficacy of amber SEL-P in 70 patients requiring peripheral embolization vascular anomalies hemorrhages aneurysms and pseudoaneurysms varicose veins portal vein hypervascular tumors type -II endoleaks and pathological organs
The study will be divided into two consecutive stages Stage I will be dedicated to testing the devices safety followed immediately by stage II aimed to test the devices efficacy The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants
The study will be divided into two consecutive stages Stage I will be dedicated to testing the devices safety followed immediately by stage II aimed to test the devices efficacy The overall study sample will be used to assess the device safety and efficacy in all the enrolled participants
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