Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT06117267
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years and ≤70 years
* Patients who need to undergo posterior cervical pedicle screw placement surgery
* The subject is willing to provide preoperative CT images and to use the navigation system during surgery for the verification of navigation image accuracy.
* Subjects are willing and able to comply with the procedures and requirements of this clinical trial.
* Subjects are able to understand and willing to sign the informed consent form.
Exclusion Criteria:
* Creutzfeldt-Jakob disease
* Known allergy to stainless steel
* Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome (AIDS), HIV infection, Severe Combined Immunodeficiency Syndrome, Thymic Hypoplasia
* Pregnant women
* Have a systematic or local infection, which may increase study risk
* Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency
* Use of anticoagulants
* Osteoporosis
* Be on uncontrolled diabetes mellitus.
* Immunologically suppressed, or has received systemic steroids, excluding nasal steroids, at any dose daily for \> 1 month within last 12 months.
* Previous history of cervical spine surgery
* Other medical conditions, as judged by a physician, may affect the physiological status for surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06117267
Study Brief:
Protocol Section:
NCT06117267