NCT06960018 Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
| NCT ID | NCT06960018 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aesculap AG |
| Condition | Cervical Spine Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2025-06-20 with a primary completion date of 2027-11.
⚠ 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
The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical approach using the Ennovate® Cervical Spinal System.
Eligibility Criteria
Inclusion Criteria: * All patients with minimum 18 years of age receiving Ennovate® Cervical internal fixation device within the vertebral bodies C2-Th3 to ensure the restoration and stabilization of the cervical spine Exclusion Criteria: * All patients not willing to sign the patient consent are excluded. Also, if it is clear from the beginning, that the patient will not be able to come to routine follow-up, the patient will also be excluded. Absolute contraindications according to the IFU: * Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant components; for example, osteopenia, severe osteoporosis, Paget's disease, bone tumors etc. * Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant system. * Suspected allergy or sensitivity to the implant materials. * Acute or chronic vertebral infections of a local or systemic nature. * Poor patient compliance or limited ability to follow medical instructions, particularly in the postop phase, including with regard to the restrictions on range of movement in terms of physical exercise and occupational activity.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06960018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cervical Spine Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06960018 currently recruiting?
Yes, NCT06960018 is actively recruiting participants. Contact the research team at studies@aesculap.de for enrollment information.
Where is the NCT06960018 trial being conducted?
This trial is being conducted at Aachen, Germany, Berlin, Germany, Freiburg im Breisgau, Germany.
Who is sponsoring the NCT06960018 clinical trial?
NCT06960018 is sponsored by Aesculap AG. The trial plans to enroll 76 participants.