| NCT ID | NCT05170815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clariance |
| Condition | Spine Degeneration |
| Study Type | OBSERVATIONAL |
| Enrollment | 760 participants |
| Start Date | 2022-01-17 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 760 participants in total. It began in 2022-01-17 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05170815 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spine Degeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05170815 currently recruiting?
Yes, NCT05170815 is actively recruiting participants. Contact the research team at f.laboulfie@clariance-spine.com for enrollment information.
Where is the NCT05170815 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT05170815 clinical trial?
NCT05170815 is sponsored by Clariance. The trial plans to enroll 760 participants.