Status:
COMPLETED
Safety and Effectiveness Study for a Needle Guidance System in Lung Biopsies
Lead Sponsor:
ActiViews Ltd.
Conditions:
Lung Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 asp...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01183182
Start Date
August 1 2010
End Date
March 1 2011
Last Update
December 21 2012
Active Locations (3)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
2
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G1Z6
3
McGill University Health Center, Royal Victoria Hospital, Montreal General Hospital
Montreal, Quebec, Canada, H3A1A1