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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT05280067
Eligibility Criteria:
Inclusion Criteria:
* Age between 22 (inclusive) and 75 years (inclusive) at the time of enrollment.
* Life expectancy of 12 months or more.
* Female patient with histologically confirmed diagnosis of primary breast cancer.
* Metastatic breast cancer to bone, with or without involvement of other sites (patients with single metastasis qualify)
* At least one lytic metastatic lesion located in the vertebral body of the spine.
* Normal spinal alignment.
* SINS ≥3 and ≤9.
* Signed and dated Informed Consent Form (ICF).
* Patient is willing and able to participate in required follow-up visits at the Investigational Site and to complete study procedures and questionnaires.
Exclusion Criteria:
* Vertebral body collapse.
* Spinal cord compression.
* Known allergy to Investigational Device materials.
* Using medications or any drug known to potentially interfere with bone/soft tissue healing (e.g., chronic systemic steroids).
* Current tobacco smoker or stopped smoking in past 6 months.
* Uncontrolled diabetes mellitus, HbAIC cutoff.
* An active systemic infection (e.g., hepatitis, acquired immunodeficiency syndrome (AIDS), AIDS-related complex (ARC).
* Currently participating in any investigational trial not related to this trial.
* Any other severe acute or chronic medical condition that may interfere with the interpretation of the trial results, in the judgment of the PI, which would make the patient inappropriate for entry into this trial.
* Pregnant or planning to become pregnant during the trial.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
22 Years
Maximum Age:
75 Years
Study:
NCT05280067
Study Brief:
Protocol Section:
NCT05280067