Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|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|
- Number of patients with successful targeting accuracy as defined by the frequency of placing the needle at a location suitable for obtaining tissue sample from the target lesion. [ Time Frame: 30 to 60 minutes after starting the biopsy procedure ] [ Designated as safety issue: Yes ]
Needle location suitable for obtaining tissue sample will be determined by a physician reviewing the CT images.
All 48 subjects undergoing aspiration or biopsy procedures with the CT met the primary efficacy endpoint of placement of the procedure needle at a location suitable for obtaining a tissue sample from the target lesion as determined by the investigator (100%; 95% CI, 93-100%).
- Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure [ Time Frame: 30 to 60 minutes ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Needle Guidance
Lung biopsies performed with the needle guidance system.
Device: ActiSight Needle Guidance System
Three different groups of patients defined per lesion size
Other Name: CT-Guide Needle Guidance System
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.
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|University Health Network, Toronto General Hospital|
|Toronto, Ontario, Canada, M5G1Z6|
|McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital|
|Montreal, Quebec, Canada, H3A1A1|
|Principal Investigator:||Paul Narinder, MD||University Health Network, Toronto|