Monitoring the safety and performance of Ennovate® Complex for scoliosis patients
Multicenter Post Market Clinical Follow-Up (PMCF) Study on the Safety and Performance of Ennovate® Complex - A Prospective Study on Scoliosis Patients
This study looks at how safe and effective the Ennovate® Complex system is for treating scoliosis and other spinal issues in patients after their surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 2 sites (Brno and 1 other locations) |
| Trial ID | NCT05281757 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on the safety and performance of the Ennovate® Complex system used for treating various spinal deformities, including scoliosis. It involves multiple centers across different countries and focuses on documenting clinical and radiological outcomes for patients who have undergone posterior stabilization for the cervical spine. The study aims to provide valuable insights into the effectiveness of the implant system in real-world settings, ensuring ongoing safety monitoring post-market.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older who have provided informed consent and are undergoing treatment for conditions like hyperkyphosis, hyperlordosis, or scoliosis.
Not a fit: Patients who are unable or unwilling to participate in follow-up examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the Ennovate® Complex system's safety and efficacy, leading to improved treatment options for patients with spinal deformities.
How similar studies have performed: While this study is part of a post-market follow-up, similar observational studies have successfully monitored the safety and performance of medical devices in the past.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brno and 1 other locations
- University Hospital Brno — Brno, Czechia (Suspended)
- Hospital Universiti Kebangsaan Malaysia (HUKM) — Kuala Lumpur, Malaysia (Recruiting)
Study contacts
- Principal investigator: Mohd Hisam, Prof. Dr. — Hospital Universiti Kebangsaan Malaysia (HUKM)
- Study coordinator: Sarah Mattes
- Email: sarah.mattes@aesculap.de
- Phone: +497461950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.