Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-02 @ 12:02 PM
Study NCT ID:
NCT04601168
Status:
TERMINATED
Last Update Posted:
2022-09-14
First Post:
2020-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
Sponsor:
Decathlon SE
Organization:
Study Overview
Official Title:
Assessment of the Safety and Performance of a Compression Knee Support in the Prevention of Injuries During Sports Practice
Status:
TERMINATED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulties of inclusion, financial considerations, review of CER (no additional clinical data needed to demonstrate safety and performance of the medical device under evaluation)
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Decathlon has developed kneeSOFT100 product which is medical device designed to reduce pain and joint instability during sport practice. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT100 product to demonstrate safety and performance of this device in a real-world setting.
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?: