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 @ 5:02 AM
Ignite Modification Date:
2025-12-25 @ 5:02 AM
NCT ID:
NCT06910618
Eligibility Criteria:
Inclusion Criteria:
* Patient 18 years or older
* Patient diagnosed with a metastatic tumor in the thoracic and/or lumbar spine (one or more vertebral metastases in the spinal region between T1 and L5 vertebrae)
* Min. 1 vertebra is potentially unstable based on SINS score (SINS is 7-12) and it has not been surgically stabilized previously (level of interest - LOI)
* Adjacent vertebrae are not surgically stabilized at the time of the enrollment
* Patient willing to complete 6-month follow-up
* Patient is willing and able to provide written informed consent after the nature of the study has been explained:
* Ability to understand the content of the patient information/ ICF
* Willingness and ability to participate in the study according to the protocol
* Signed and dated EC approved written informed consent
Exclusion Criteria:
* Poor general status at baseline (Karnofsky scale less than 40%)
* Expected life expectancy is less than 3 months at baseline
* Spinal infection
* Ongoing litigation
* Participation in investigational clinical study at the same time or within 3 months
* Vertebral lesion/metastasis from a hematologic condition (e.g. multiple myeloma)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06910618
Study Brief:
Protocol Section:
NCT06910618