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 @ 2:13 AM
Ignite Modification Date:
2025-12-25 @ 2:13 AM
NCT ID:
NCT07018960
Eligibility Criteria:
Inclusion Criteria
Patients must meet ALL of the following:
• Age: ≥18 years
Clinical Indication:
* Requires chest wall reconstruction due to:
* Oncologic resection (primary tumors, metastases)
* Traumatic injury (flail chest, severe rib fractures)
* Post-infection/post-radiation defects
* Defect Characteristics:
* Involves ≥2 ribs or sternum with instability
* Minimum defect size: 5 cm in largest dimension
* Surgical Plan:
* Scheduled for reconstruction with 3D-printed custom titanium prosthesis
* Consent: Willing to provide informed consent for:
* Surgery
* Data collection
* Follow-up evaluations
* Exclusion Criteria
Patients will be excluded if ANY of the following apply:
* Medical Contraindications:
* Active systemic infection (e.g., sepsis)
* Severe cardiopulmonary disease (FEV₁ \<30% predicted)
* Uncorrectable coagulopathy (INR \>1.5)
* Technical Limitations:
* Inadequate soft tissue coverage for prosthesis
* Vertebral column involvement requiring complex fixation
* Material Incompatibility:
* Known hypersensitivity to titanium alloys
* Study Logistics:
* Participation in another conflicting clinical trial
* Inability to complete follow-up (e.g., no fixed address)
* Ethical Considerations:
* Pregnancy (due to elective CT scan requirements)
* Prisoners or cognitively impaired patients without legal guardians
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07018960
Study Brief:
Protocol Section:
NCT07018960