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:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT05631392
Eligibility Criteria:
Inclusion Criteria:
1. Subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature.
2. Subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from C3 to C7, and confirmed by imaging studies (CT and/or MRI will be taken according to standard local procedures and confirmed by the Investigator that imaging represents the indication for surgery).
3. Subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated.
4. Subjects who are indicated for surgical treatment with the BEE® HA Cage with RESORBA® Synthetic Bone injectable bone substitute (RESORBA Medical GmbH).
5. Subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief.
Exclusion Criteria:
1. Subjects who have undergone previous spinal surgery either anterior or posterior.
2. Subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years.
3. Subjects with a known allergy to the material used in the instrumentation.
4. Subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study.
5. Subjects who have known osteoporosis or severe osteopenia as determined by the Investigator.
6. Subjects who have any conditions outlined as contraindicated in the Instructions for Use.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05631392
Study Brief:
Protocol Section:
NCT05631392