Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465940
Status:
COMPLETED
Last Update Posted:
2024-06-20
First Post:
2024-06-14
Brief Title:
Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
Sponsor:
Societe dEtude de Recherche et de Fabrication
Organization:
Societe dEtude de Recherche et de Fabrication
Study Overview
Official Title:
Observational Ambispective Study on HYPE Cups Associated With HIPER Liner
Status:
COMPLETED
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:
None
Brief Summary:
This study intend to collect data on total hip arthroplasty performed with HYPE cups used with conventional polyethylene liner HIPER
Medical Device Regulation 2017745 regulation required proper clinical data to support claims This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047745 regulation
Medical Device Regulation 2017745 regulation required proper clinical data to support claims This study is therefore intended to provide data on HYPE devices to comply with Medical Device Regulation2047745 regulation
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