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 @ 4:01 AM
Ignite Modification Date:
2025-12-25 @ 4:01 AM
NCT ID:
NCT00562302
Eligibility Criteria:
Inclusion Criteria:
* The patient must meet all medical conditions for lung biopsy;
* The patient must be at least 18 years of age;
* The patient, or legal representative, must understand and provide written consent for the procedure;
* The patient has a non-calcified, radiologically suspicious opacity or lung nodule, including a metastatic lung module, or mass of at least 1.0 cm in size; as determined by CT scan equipped with measurement software. Suspicious nodules observed by CT scan are defined as non-calcified masses with convex borders, not known to be stable. Suspicious nodules can also be defined as masses demonstrating opacity on chest x-ray that are suspicious by radiographic or clinical means and require biopsy.
Exclusion Criteria:
* Patients with radiological findings of bullous emphysema located in the area of the anticipated biopsy and biopsy needle track;
* Patients who cannot tolerate mild sedation, possibly secondary to poor respiratory status;
* Female patients who are pregnant. Note: patients of childbearing potential must have a serum or urine pregnancy test no more than one week prior to the biopsy procedure, and be instructed not to have unprotected sexual intercourse after the test until the biopsy procedure is completed.
* Patients who are uncooperative or cannot follow instructions.
* Patients who are currently enrolled in another IDE or IND clinical investigation that has not completed the required follow-up period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00562302
Study Brief:
Protocol Section:
NCT00562302