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
Verified date | March 2011 |
Source | ActiViews Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | March 2011 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital | Montreal | Quebec |
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Canada | University Health Network, Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
ActiViews Ltd. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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%). |
30 to 60 minutes after starting the biopsy procedure | Yes |
Secondary | Total CT-Guided procedure time Patient radiation exposure during the procedure Number of CT scans during the procedure | 30 to 60 minutes | Yes |
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