Status:
COMPLETED
Safety & Accuracy Study of the ActiSight Needle Guidance System in Patients Undergoing CT-Guided Percutaneous Chest Aspiration and Biopsy
Lead Sponsor:
ActiViews Ltd.
Conditions:
Biopsy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Why is this study conducted to demonstrate the safety and effectiveness of the ActiSight Needle Guidance System in assisting trained physicians perform CT guided percutaneous needle biopsy (PNB) and f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00819533
Start Date
January 1 2008
End Date
October 1 2009
Last Update
December 29 2009
Active Locations (1)
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1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada