Clariance ErYs Registry

Launched by CLARIANCE · Dec 8, 2021

Keywords

ClinConnect Summary

The Clariance ErYs Registry is a clinical trial that aims to gather information about the safety and effectiveness of certain spine devices used to treat various spine conditions, such as degeneration, spondylosis, deformities, tumors, and fractures. This study will follow patients before, during, and after their surgery, checking in at specific times (9 weeks, 6 months, 1 year, and 2 years) to see how well the devices work and if they cause any complications. The goal is to show that these devices can help reduce pain and improve the quality of life for patients.

To participate in this trial, you need to be an adult (at least 18 years old in France or 21 years old in the United States) and have a medical need for one of the spine devices being studied. However, if you have difficulty understanding study questions or keeping scheduled appointments, or if you are a minor, pregnant, or under legal protection, you may not be eligible. Participants can expect regular check-ups and support throughout the study period, helping doctors understand how these devices perform in everyday situations.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States).
• • Indicated for treatment with one or more commercially available sponsor spine device included into the study.
• • For France only, affiliated with or beneficiary of a social security scheme.
• Exclusion Criteria:
• • Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times).
• • Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship).
• • Contraindicated for spine surgery utilizing a commercially available sponsor spine device.