Biopsy Clinical Trial
Official title:
A Prospective, Open-Label, Single-Arm, Single-Center Study Evaluating the Preliminary Safety and Accuracy of the ActiSight Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy
Verified date | December 2009 |
Source | ActiViews Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
This study is designed to evaluate preliminary safety and accuracy of the ActiSight™ Needle Guidance System in patients undergoing CT-guided lung aspiration or biopsy. This image guidance system uses a combination of CT scans and camera images to help guide a biopsy needle to a lung lesion. The system displays a simulated image of a biopsy needle and its estimated path for the biopsy.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 2009 |
Est. primary completion date | October 2009 |
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 meeting all medical conditions for percutaneous chest aspiration/biopsy with safe path to lesion between ribs, however, not in the breast area in women or men with gynecomastia - Single target pulmonary lesion greater than 10 mm in size (diameter) and depth of lesion greater than 40 mm from the skin - Written informed consent to participate in the study - Ability to comply with the requirements of the study procedures Exclusion Criteria: - Fibrous tissue or cyst in access path (not including target lesion) - Hemophilia, thrombocytopenia, coagulopathy, or other elevated risk for bleeding or abnormal clotting - Use of ticlodipine or similar antithrombotic medication - For subjects taking warfarin or other anticoagulant medication, INR >1.3 - Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia - Patient is unable to comply with requirements of the procedure, i.e. holding breath - Participation in any prior investigational trial within 30 days of enrollment - Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder, or any chronic condition that could, in the opinion of the investigator, of interfering with the conduct of the study. - Subjects who are uncooperative or cannot follow instructions |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network, Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
ActiViews Ltd. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of target reached within a radius of 5 mm from the preplanned targeted point as measured on the final CT scan | Measure evaluated during entire course of study | No | |
Secondary | Number of punctures required to obtain sample | Measure evaluated during entire course of study | No | |
Secondary | Number of intermediate CT scans required to obtain sample | During entire course of study | No | |
Secondary | An adequate sample obtained during the procedure | during entire course of study | No |
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