Status:
COMPLETED
Effectiveness of ActiSight™ Needle Guidance System in Patients Undergoing CT-Guided Procedures
Lead Sponsor:
ActiViews Ltd.
Conditions:
Lung Diseases
Liver Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To assist in guiding a rigid interventional instrument percutaneously, to a designated point within the body by means of CT visualization.
Detailed Description
The ActiSight™ Needle Guidance System is an optical navigation system designed to assist physicians performing percutaneous interventions under CT guidance. The system allows the user to select an obs...
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 CT guided. procedures in the chest, abdomen or pelvic, with safe path to lesion.
- Written informed consent to participate in the study.
- Ability to comply with the requirements of the study procedures.
Exclusion
- Having co-morbidities that would clinically preclude them from an image guided procedure as determined by the operating physician.
- Significant coagulopathy that cannot be adequately corrected.
- Patients who have a medical contraindication to sedation (Lidocaine allergy).
- Pregnancy or lactation.
- Participation in an investigational trial within 30 days of enrollment.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01148706
Start Date
July 1 2010
End Date
September 1 2012
Last Update
December 11 2012
Active Locations (1)
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1
Carmel Medical Center
Haifa, Israel