RecruitingNot ApplicableNCT06960018

Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement

Controlled, Randomized Clinical Study to Demonstrate the Patient Benefit and Safety of Pedicle Screw Placement Through an Innovative Minimally Invasive Surgical Approach Using the Ennovate® Cervical Spinal System


Sponsor

Aesculap AG

Enrollment

76 participants

Start Date

Jun 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Ennovate® Cervical, minimal invasive surgical technique and a medical device called Ennovate® Cervical, open surgical technique for people with cervical spine disease and pain, postoperative. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEnnovate® Cervical, open surgical technique

Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of * Fractures * Degenerative instability * Post-trauma instability * Tumors * Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using an open surgical technique

DEVICEEnnovate® Cervical, minimal invasive surgical technique

Patients with need of posterior monosegmental and multisegmenta stabilization of the cervical and upper thoracic spine, because of * Fractures * Degenerative instability * Post-trauma instability * Tumors * Degenerative cervical myelopathy due to multilevel subaxial spinal canal stenosis will be treated with Ennovate® Cervical system using a minimally invasive technique.


Locations(3)

Universitätsklinikum Aachen

Aachen, Germany

Charité Berlin

Berlin, Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

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NCT06960018


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