Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631157
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-02
Brief Title:
Essential Pro Study rEPIC04E-HK
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Essential Pro Post-Market Clinical Follow-up Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
rEPIC04E-HK
Brief Summary:
Single center 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:
This study intends to analyze
Device effectiveness in its individual use technical performance and procedural effectiveness technical outcome at the end of lesion treatment with the device under study and any other device being used
Device safety in its individual use technical performance and procedural safety technical outcome at the end of lesion treatment with the device under study and any other device being used
Clinical outcomes at the end of the procedure and during the specified follow-up period for each device The follow-up timeframe is established based on the conditions of use and type of device being used according to the requirements established by the relevant Notified Body
Device effectiveness in its individual use technical performance and procedural effectiveness technical outcome at the end of lesion treatment with the device under study and any other device being used
Device safety in its individual use technical performance and procedural safety technical outcome at the end of lesion treatment with the device under study and any other device being used
Clinical outcomes at the end of the procedure and during the specified follow-up period for each device The follow-up timeframe is established based on the conditions of use and type of device being used according to the requirements established by the relevant Notified Body
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