Ignite Creation Date:
2024-10-25 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587282
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
PREEMIE Study for Treatment of PDA in Premature Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Single Arm Prospective Non-Randomized Study Designed to Evaluate the Safety and Effectiveness of the BLOOM Micro-Occluder System for the Treatment of Patent Ductus Arteriosus PDA in Pre-mature Infants PREMIE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREEMIE
Brief Summary:
This multicenter single arm prospective non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus PDA in pre-mature infants over a period of 6 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None