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Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice

Epicondylitis Clinical Trial

Official title:
Assessment of the Safety and Performance of an Elbow Brace in the Prevention of Injuries During Sports Practice

Clinical Trial Summary

Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device in a real-world setting. Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon ElbowSoft300 device and support peer-reviewed publications on products performance and safety.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05552235
Study type Interventional
Source Decathlon SE
Contact Jean HEE
Phone 07 64 35 00 45
Email jean.hee@btwin.com
Status Recruiting
Phase N/A
Start date November 15, 2022
Completion date March 2023
View Details
See also
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