Clinical trial · Observational
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Multicenter Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical - a Prospective Study on Total Indications
NCT05296889CI-TRIAL-00120293CERISErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Degenerative Disc Disease | — | UNRESOLVED | — |
| Degenerative Myelopathy | — | UNRESOLVED | — |
| Spinal Instability | — | UNRESOLVED | — |
| Spinal Tumor | — | UNRESOLVED | — |
| Spine Fracture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| posterior stabilization for the cervical spine | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Ennovate® Cervical
- description
- Alll patients which were treated with the Ennovate® Cervical system in accordance with the indications given in the instructions for use
- interventionNames
- Device: posterior stabilization for the cervical spine
Primary outcomes (1)
- measure
- Change of Pain
- timeFrame
- preoperatively, at 3 months postoperatively and at 12 months postoperatively
- description
- Pain will be assessed by the patient using the Visual Analogue Scale (VAS) which states "0" at one end representing "no pain" and "100" at the opposite end representing "maximal/worst pain".
Secondary outcomes (5)
- measure
- Change of Quality of life
- timeFrame
- preoperatively, at 3 months postoperatively and at 12 months postoperatively
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.