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The trial is taking place at:
C

Centre Hospitalier Universitaire de Lille | Claude Huriez Hospital - Gastroenterology Department

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

D

Decathlon

Status

Enrolling

Conditions

Epicondylitis
Tendonitis Elbow
Elbow Injury

Treatments

Device: Elbow SOFT 300
Other: Control group

Study type

Interventional

Funder types

Industry

Identifiers

NCT05552235
elbowSOFT300

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject is aged ≥ 18 years old
  • Subject has a chronic epicondylitis (>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (>3 months)
  • The current condition of his/her elbow allows the subject to continue usual physical activity
  • Subject has been informed and is willing to sign an informed consent form
  • Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
  • Subject is affiliated to the French social security regime

Exclusion criteria

  • Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
  • Subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice
  • Subject has any medical condition that could impact the study at investigator's discretion
  • Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, polyester, elastane)
  • Adult subject to legal protection measure

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

Orthosis group
Experimental group
Description:
Use of Elbow Soft 300 device during sport practice
Treatment:
Device: Elbow SOFT 300
Control group
Other group
Description:
No medical device used during sport practice
Treatment:
Other: Control group

Trial contacts and locations

2

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Central trial contact

Jean HEE; Sophie TALLON

Data sourced from clinicaltrials.gov

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