Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
NCT05281757 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-04-15
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)
Conditions
- Hyperkyphosis
- Hyperlordosis
- Congenital Scoliosis
- Neuromuscular Scoliosis
- Idiopathic Scoliosis
Interventions
- DEVICE
-
posterior stabilization for the cervical spine
The Ennovate® Complex Spinal System is a posterior stabilization for the Complex and upper-thoracic spine. The implants are used for the posterior multisegmental correction and stabilization over all sections of the spine.
Sponsors & Collaborators
-
Raylytic GmbH
collaborator INDUSTRY -
Aesculap AG
lead INDUSTRY
Principal Investigators
-
Mohd Hisam, Prof. Dr. · Hospital Universiti Kebangsaan Malaysia (HUKM)
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-18
- Primary Completion
- 2026-04-30
- Completion
- 2028-10-31
Countries
- Czechia
- Malaysia
Study Locations
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