Lung Diseases Clinical Trial
Official title:
Confirmation of Clinical Effectiveness and Safety of CT-guided Percutaneous Lung Aspiration and Biopsy Performed With the Aid of the ActiSightTM Needle Guidance System
This study is designed to provide clinical data regarding safety and clinical effectiveness of the ActiSight Needle Guidance System in assisting radiologically guided percutaneous needle biopsy or aspiration of pulmonary lesions, which is a common procedure.
This will be a prospective, single-arm study. At least three centers in Canada will
participate in the study and at least 4 different experienced staff radiologists will
perform the procedures for the study.
A total of forty eight (48) consecutive subjects meeting the eligibility criteria, scheduled
for clinically indicated CT guided lung biopsy or aspiration procedure at the participating
centers will be invited to enroll in the study. To ensure diversity in the study population,
consecutive patients will be enrolled in the following groups until these groups are fully
enrolled:
Lesion size ≥1.0 cm and ≤ 1.5 cm: 10 patients; Lesion size >1.5 and ≤ 3.0 cm: 19 patients;
Lesion size >3.0 cm: 19 patients.
A maximum of 24 patients will be enrolled at each center.
Informed consent will be signed prior to the procedure. Subject data collection on the day
of the procedure will include demographics, relevant medical history and vital signs.
Enrolled subjects will undergo CT guided percutaneous lung aspiration and/or biopsy as
clinically indicated by a qualified physician, utilizing the ActiSight Needle Guidance
System. Subjects will be followed-up as outlined below to assess adverse events related to
the procedure. A subject's enrollment in the study will be completed after the follow-up
visit or after resolution of any procedure related adverse event.
A procedure difficulty classification is defined for this study, based on existing
literature. Difficulty levels for all procedures will be recorded and included in the final
report.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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