Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-01-01 @ 3:16 PM
Study NCT ID:
NCT04751266
Status:
COMPLETED
Last Update Posted:
2022-04-19
First Post:
2016-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE)
Sponsor:
Dr. Caroline Fortmann
Organization:
Study Overview
Official Title:
Examination of Metal Contamination After Minimally Invasive Repair of Pectus Excavatum (MIRPE) and the Clinical Relevance
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
The purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. Our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to elevated metal contamination.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: