Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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 selected centers (not interventional, multicentric)
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Malaysia
Hospital Universiti Kebangsaan Malaysia (HUKM)
RECRUITING
Kuala Lumpur
Contact Information
Primary
Sarah Mattes
sarah.mattes@aesculap.de
+497461950
Backup
Stefan Maenz
stefan.maenz@aesculap.de
+497461950
Time Frame
Start Date: 2022-02-18
Estimated Completion Date: 2028-10
Participants
Target number of participants: 200
Treatments
Ennovate® Complex
All patients who are treated with the Ennovate® Complex system in accordance with indications given in the instructions for use (IFU)
Related Therapeutic Areas
Sponsors
Leads: Aesculap AG
Collaborators: Raylytic GmbH