Status:
RECRUITING
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
Raylytic GmbH
Conditions:
Hyperkyphosis
Hyperlordosis
Eligibility:
All Genders
Brief Summary
Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in s...
Detailed Description
This clinical study is one of the Post-Market Clinical Follow-Up (PMCF) measures that enables the manufacturer to monitor the clinical safety and performance of the Ennovate® Complex system. The stud...
Eligibility Criteria
Inclusion
- 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
- Patient's clear unability or unwillingness to participate in follow-up examinations
Key Trial Info
Start Date :
February 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05281757
Start Date
February 18 2022
End Date
October 1 2028
Last Update
May 7 2025
Active Locations (2)
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1
University Hospital Brno
Brno, Czechia, 62500
2
Hospital Universiti Kebangsaan Malaysia (HUKM)
Kuala Lumpur, Malaysia