Status:
COMPLETED
Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy
Lead Sponsor:
ActiViews Ltd.
Conditions:
Biopsy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.
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
- INR \<1.3
- 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
- Central lesion is located in radius of less than 2 cm from lobar blood vessels and the heart.
- The selected needle path has a safety margin of less than 2 cm from major blood vessels and the heart
- Use of ticlopidine or similar antithrombotic medication
- For subjects taking warfarin or other anticoagulant medication, INR \>1.3
- Pulmonary hypertension, heart failure, renal failure, or blood dyscrasia
- Subjects who cannot tolerate mild sedation
- Subjects with FEV1 \< 800 mL unless approved by principal investigator following consultation with multidisciplinary team
- Subjects with the following laboratory values, unless approved by hematologist:
- Platelet count \<100,000/mL
- APTT \>39 sec or PT \>15 sec
- Pregnancy or lactation
- Patient is unable to comply with requirements of the procedure, i.e. holding breath
- Participation in an 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 :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00814450
Start Date
December 1 2008
End Date
June 1 2009
Last Update
December 30 2009
Active Locations (1)
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1
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239