Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical

Launched by AESCULAP AG · Mar 16, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a device called Ennovate® Cervical, which is used to treat various spine conditions such as fractures, degenerative disc disease, spinal instability, tumors, and degenerative myelopathy. The study aims to gather information from patients who have received this treatment to better understand its performance over time.

To participate in the trial, individuals must be at least 18 years old and able to provide consent for their medical information to be collected. Participants should have a specific spine condition that the device is designed to treat and cannot be pregnant. During the study, participants will be asked to attend follow-up examinations to monitor their health and the results of the treatment. This research is important as it will help ensure that the Ennovate® Cervical device is both safe and effective for patients with these spine issues.

Gender

ALL

Eligibility 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