NCT05281757 Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
| NCT ID | NCT05281757 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Hyperkyphosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-02-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-02-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 selected centers (not interventional, multicentric)
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
Contact & Investigator
Mohd Hisam, Prof. Dr.
PRINCIPAL INVESTIGATOR
Hospital Universiti Kebangsaan Malaysia (HUKM)
Frequently Asked Questions
Who can join the NCT05281757 clinical trial?
This trial is open to participants of all sexes, studying Hyperkyphosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05281757 currently recruiting?
Yes, NCT05281757 is actively recruiting participants. Contact the research team at sarah.mattes@aesculap.de for enrollment information.
Where is the NCT05281757 trial being conducted?
This trial is being conducted at Brno, Czechia, Kuala Lumpur, Malaysia.
Who is sponsoring the NCT05281757 clinical trial?
NCT05281757 is sponsored by Aesculap AG. The principal investigator is Mohd Hisam, Prof. Dr. at Hospital Universiti Kebangsaan Malaysia (HUKM). The trial plans to enroll 200 participants.