Status:
RECRUITING
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
Raylytic GmbH
Conditions:
Spine Fracture
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Brief Summary
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
Detailed Description
This clinical study is one of the Post market clinical follow-up measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Cervical system. The study enabl...
Eligibility Criteria
Inclusion
- 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
- Patient's clear unability or unwillingness to participate in follow-up examinations
Key Trial Info
Start Date :
July 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05296889
Start Date
July 21 2021
End Date
December 1 2026
Last Update
February 12 2025
Active Locations (4)
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1
Krankenhaus Ludmillenstift Meppen
Meppen, Lower Saxony, Germany, 49716
2
Städtisches Klinikum Dresden
Dresden, Saxony, Germany, 01076
3
Berufsgenossenschaft Klinikum Bergmannstrost Halle / Saale
Halle, Saxony-Anhalt, Germany, 06112
4
Schön Klinik Hamburg Eilbek
Hamburg, Germany, 22081