Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies

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.

Inclusion criteria

• Male or female subjects, 18 years of age or older at the time of enrollment;
• Subjects scheduled for clinically indicated CT guided percutaneous lung aspiration/biopsy;
• Written informed consent to participate in the study;
• Ability to comply with the requirements of the study procedures;
• Verified home address and phone number to facilitate study follow-up.

Exclusion criteria

• Significant coagulopathy that cannot be adequately corrected;
• Subjects who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment;
• Subjects with preexisting conditions which, in the opinion of the investigator, interfere with the conduct of the study;
• Subjects who are uncooperative or cannot follow instructions;
• Mental impairment that may preclude completion of the study procedure;
• Pregnant or nursing female subjects.