Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT05672069
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2023-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
Sponsor:
Societe dEtude, de Recherche et de Fabrication
Organization:
Study Overview
Official Title:
Ambispective, Multicentre, Open-label Study Evaluating the Clinical Outcomes of Foot Surgery Using SERF Medical Devices
Status:
COMPLETED
Status Verified Date:
2024-04
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:
This clinical investigation was led as a post-marketing clinical follow-up study conducted as part of standard care with an additional, non-invasive, non-invasive procedure (Case 4.1) ambispective, multicentre, open-label, non-comparative.
The primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status.
The target population for this study was any adult patient implanted with FAST screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and october 2022.
The investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679.
The primary objective of this study is to evaluate the reduction in patient pain and the restoration of walking. The study will also collect performance and safety data to assess the subject's outcomes and functional status.
The target population for this study was any adult patient implanted with FAST screws, FAST plates, Toe FAST and VEOFIX screws between november 2021 and october 2022.
The investigation will be conducted in accordance with the investigation protocol, the laws and regulations (including the Medical regulations (including the Medical Devices Regulation 2017/745) and the ISO 14155:2020, as well as in accordance with the ethical principles described in the Declaration of Helsinki. The collection of personal data will also be compliant with RGPD 2016/679.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: