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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT01280032
Eligibility Criteria:
Inclusion Criteria:
* ≥ 50 years
* Karnofsky Index ≥ 60
* histological or by imaging proven spinal metastases (2 cm diameter as the upper limit) inferior TH 3, which are accessible for kyphoplasty
* written informed consent obtained
* use of adequate contraceptive method by female patients of reproductive potential to minimize risk of pregnancy
Exclusion Criteria:
* uncontrolled intercurrent medical disorder - including but not limited to ongoing or active infection (including infections in the area of the treated spinal segment, for example, spondylitis / osteomyelitis / skin infections) or mental illness / social situation which affect the compliance of study requirements
* prior radiation of the same vertebra
* patients could not receive anaesthesia or surgery for medical reasons
* history of coagulation disorder associated with bleeding
* existing contraindications for MRI- or CT-scans
* pregnant or breast-feeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT01280032
Study Brief:
Protocol Section:
NCT01280032