RecruitingOBSERVATIONAL

Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World

This study is checking how well and safely certain Chattanooga Intelect® medical devices work in real-life situations. These devices are used to treat problems with muscles, bones, and joints (musculoskeletal disorders). The goal is to collect information on how these devices, which include specific Intelect® Mobile and Transport models, are used by healthcare professionals. This helps make sure the devices continue to be safe and effective for patients and comply with important medical device regulations. It's an observational study, meaning researchers will watch and record what happens during normal treatment, rather than asking people to do anything different.

At a glance

Status

Recruiting

Sponsor

DJO UK Ltd

Enrolment target

144

Start

10 Mar 2025

Estimated completion

01 Dec 2026

Musculoskeletal Disorders Skeletal Disorder Muscle Disorder

What is this study about?

This study is being carried out by DJO UK Ltd (ENOVIS) and is looking into how well and how safely certain medical devices, called Chattanooga Intelect® devices, perform in everyday healthcare settings. These devices are designed to help people with various problems related to their muscles, bones, and joints.

The main purpose of this research is to gather information about these specific Intelect® devices during their normal use. This helps the company make sure the devices continue to be safe and are working as expected for patients in the real world. It also helps them check that the devices are being used correctly and for their intended purposes, in line with important safety regulations for medical equipment.

It's important to know that this is an 'observational' study. This means that if you were part of it, you wouldn't be asked to change your treatment in any way. Instead, doctors would simply observe and record information about how the Intelect® device is used as part of your regular care for your muscle, bone, or joint condition.

Key takeaways

Observational study of existing Chattanooga Intelect® devices.
Aimed at confirming safety and performance in real-world use.
For adults (18+) with muscle, bone, or joint conditions.
No changes to your regular medical treatment if you participate.
Helps ensure continued device safety and effectiveness for all.

Who may be eligible?

To be considered for this study, you would need to be an adult (18 years or older) and have a muscle, bone, or joint condition that your doctor plans to treat with one of the Chattanooga Intelect® devices mentioned in the study. Your doctor would decide if this treatment is right for you as part of your usual care.

You would also need to be able to understand the study information and give your written consent, meaning you agree to participate. For people in France, there's an additional requirement to be part of the social security system.

You would not be able to join if you are currently in another clinical study or finished one very recently (within the last 30 days). Also, if your doctor believes, for any health reason or other concern, that participating isn't suitable for you, then you wouldn't be able to take part.

Quick self-check

Are you 18 years old or older?
Do you have a muscle, bone, or joint condition?
Has your doctor planned to treat you with an Intelect® device?
Can you provide written agreement to participate?
Are you NOT currently in another clinical study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you were to take part in this study, you wouldn't need to do anything extra or different from your usual medical care. The study is 'observational,' which means researchers will simply collect information about how the Intelect® device is used during your standard treatment for your muscle, bone, or joint condition. There are no additional visits, specific tests, or new medications involved in the study itself. You would continue to receive care as decided by your doctor, and the study would gather information from your routine treatment.

Potential risks and benefits

Since this is an observational study and involves devices already in routine use, there are no additional risks beyond those associated with your standard medical treatment. The potential benefit is that by participating, you help improve our understanding of how these devices perform in real-world settings, which contributes to ensuring their continued safety and effectiveness for all patients. You always have the right to withdraw from the study at any time without affecting your medical care.

Locations (4)

Attal Cabinet
Serris, France· Completed
Casertafisio
Caserta, Italy· Recruiting
Rachis Center
Roma, Italy· Recruiting
Dr Chad Woods Physiotherapy
Peebles, United Kingdom· Recruiting

Common questions

What kind of devices are being studied?

The study is looking at specific Chattanooga Intelect® devices, which are commonly used in physiotherapy and rehabilitation to treat muscle, bone, and joint problems.

Will I receive a new or experimental treatment?

No, you won't. The study observes devices that are already approved and used in routine clinical practice for your condition.

How long does participation last?

Participation duration is not specified, but it's tied to your routine treatment with the device, which your doctor will determine.

Will my personal data be kept private?

Yes, all data collected in clinical studies is handled with strict confidentiality to protect your privacy.

Why is this study important?

This study helps ensure that these medical devices continue to be safe and work well for patients in everyday use, as required by medical device regulations.

How to find out more

Elena Arcangeli

elena.arcangeli@enovis.com 3498772528 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.