NCT05277818 Post-marketing Clinical Follow-up of the Medical Device DIVA®
| NCT ID | NCT05277818 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SC Medica |
| Condition | Lumbar Disc Herniation |
| Study Type | OBSERVATIONAL |
| Enrollment | 822 participants |
| Start Date | 2022-09-07 |
| Primary Completion | 2027-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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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 822 participants in total. It began in 2022-09-07 with a primary completion date of 2027-03-15.
⚠ 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
Observational, ambispective, longitudinal, comparative, open, multicentric study. The main objective is to compare the performance of care in patients operated with and without DIVA®.
Eligibility Criteria
Inclusion Criteria: * Adult patient, having undergone surgery for a degenerative or traumatic mono-segmental lumbar disc herniation, without any other associated pathology, operated with or without a DIVA® implant; * Patient operated for at least 12 months; * Patient able to understand the information related to the study; * Patient having indicated his/her non-opposition to the collection of his/her personal data. Exclusion Criteria: * History of pathologies, malformations or surgical interventions on the spine; * Patient belonging to the first 30 operated by the surgeon with the DIVA® implant; * Protected patient (under legal protection, or deprived of liberty by judicial or administrative decision); * Patient not benefiting from a social security scheme.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05277818 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lumbar Disc Herniation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05277818 currently recruiting?
Yes, NCT05277818 is actively recruiting participants. Contact the research team at dpo@sc-medica.com for enrollment information.
Where is the NCT05277818 trial being conducted?
This trial is being conducted at Colmar, France.
Who is sponsoring the NCT05277818 clinical trial?
NCT05277818 is sponsored by SC Medica. The trial plans to enroll 822 participants.