Monitoring the safety and performance of Ennovate® Cervical implants
Official title: Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications
Run by Aesculap AG · NCT05296889 · Data updated 2026-11-12
This study is looking at how safe and effective the Ennovate® Cervical implants are for patients with different spinal problems like fractures and disc disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 4 sites (Hamburg, Free and Hanseatic City of Hamburg and 3 other locations) |
| Status | Recruiting |
| Started | July 21, 2021 |
| Main results expected | August 2027 |
| Study ends | September 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT05296889 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older who require cervical spine stabilization and meet the study's inclusion criteria.
✕Probably not a fit
Patients who are unable or unwilling to participate in follow-up examinations may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study collects data on the safety and performance of the Ennovate® Cervical system used in patients with various spinal conditions. It aims to document clinical outcomes and evaluate the efficacy of the implant system in treating spine fractures, degenerative disc disease, spinal instability, spinal tumors, and degenerative myelopathy. The study involves multiple centers and focuses on gathering detailed information from patients who have received the implant, ensuring comprehensive follow-up and assessment of results.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the Ennovate® Cervical system's effectiveness and safety, leading to improved patient outcomes.
How similar studies have gone: Other studies on post-market surveillance of spinal implants have shown success in monitoring safety and performance, indicating that this approach is validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient is minimum 18 years old * Informed Consent in the documentation of clinical and radiological results * Patient has indication according to Instructions for Use (IFU) * Patient is not pregnant Exclusion Criteria: * Patient's clear unability or unwillingness to participate in follow-up examinations
Where it's running
-
Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale
Halle, Saxony-Anhalt, Germany Recruiting -
Schön Klinik Hamburg Eilbek
Hamburg, Free and Hanseatic City of Hamburg, Germany Active not recruiting -
Krankenhaus Ludmillenstift Meppen
Meppen, Lower Saxony, Germany Not yet recruiting -
Städtisches Klinikum Dresden
Dresden, Saxony, Germany Not yet recruiting
Study contacts
- Study coordinator: Sarah Mattes
- Email: sarah.mattes@aesculap.de
- Phone: +497461950
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.