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

Launched by AESCULAP AG · Mar 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and performance of a medical device called Ennovate® Complex, which is used to treat various types of spinal deformities, such as hyperkyphosis (excessive curvature of the upper back), hyperlordosis (excessive curvature of the lower back), congenital scoliosis (spinal deformities present at birth), neuromuscular scoliosis (caused by conditions affecting the nerves and muscles), and idiopathic scoliosis (curvature of the spine with no known cause). The trial is currently recruiting participants from different centers and is focused on collecting data from patients who have received this treatment.

To be eligible for the study, participants must be at least 18 years old and provide consent to have their clinical and imaging results documented. For younger patients, a parent or legal guardian must also give consent. Participants should not be pregnant and should be willing to attend follow-up examinations. Throughout the study, participants can expect to help researchers gather important information that could improve the understanding of the Ennovate® Complex device's effectiveness and safety. It's important to note that this study is observational, meaning that patients will not receive any specific treatments as part of the trial; rather, the focus is on collecting information about their experiences and outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed consent in the documentation of clinical and radiological results of patients who are minimum 18 years old
• • Informed consent in the documentation of clinical and radiological results of patients AND legal representative (parent) for patients who are younger than 18
• • Patient's indication according to IFU
• • Patient is not pregnant
• Exclusion Criteria:
• • Patient's clear unability or unwillingness to participate in follow-up examinations