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Assessment of the Safety and Performance of a Lumbar Belt

Low Back Pain Clinical Trial

Official title:
Assessment of the Safety and Performance of a Lumbar Belt

Clinical Trial Summary

Decathlon has developed the Lumbar belt Soft 300 and Mid 500 products which are medical devices designed to reduce pain and improve function during sport practice for athletes with a common subacute or chronic low back pain. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Lumbar belt range of products to demonstrate safety and performance of these devices 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 lumbar belt Soft 300/ Mid 500 devices 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 NCT05552248
Study type Observational
Source Decathlon SE
Contact Jean HEE
Phone 07 64 35 00 45
Email jean.hee@btwin.com
Status Recruiting
Phase
Start date September 23, 2022
Completion date December 2023
View Details
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