Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-01 @ 9:19 PM
Study NCT ID:
NCT05292092
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2022-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Essential Pro PMCF Study ( rEPIC04E )
Sponsor:
Fundación EPIC
Organization:
Study Overview
Official Title:
Essential Pro Post-Market Clinical Follow-up Study
Status:
RECRUITING
Status Verified Date:
2025-06
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:
rEPIC04E
Brief Summary:
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.
Detailed Description:
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Essential Pro in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
Study Oversight
Has Oversight DMC:
True
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?: