Safety & Accuracy of the ActiSight Needle Guidance System in Percutaneous Chest Aspiration and Biopsy

Study Overview
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Brief Summary
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This study is intended to provide clinical data regarding safety and accuracy of the ActiSight™ Needle Guidance System in assisting Chest CT guided biopsies.

Official Title
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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

Conditions
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Biopsy

Intervention / Treatment
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* Device: Biopsy needle guidance system (ActiSight™)


Participation Criteria
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Eligibility Criteria
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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 INR <1.3 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Biopsy needle guidance system (ActiSight™)|The ActiSight system assists in guiding an aspiration or biopsy needle, to a designated point within the body by means of CT visualization.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of target reached within a radius of 8 mm from the preplanned targeted point as measured on the final CT scan. |  | Measure evaluated during entire course of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of needle punctures through the skin |  | Measure evaluated during entire course of study | 
| Number of needle punctures through the pleura |  | Measure evaluated during entire course of study | 
| Number of CT scans needed |  | Measure evaluated during entire course of study | 
| Radial distance at target plane at the needle's final position as shown on the ActiSight screen |  | Measure evaluated during entire course of study | 
| Adverse events following the procedure, including the following:Pneumothorax, Hemoptysis >100 ml, Bleeding, Collapsed lung, Chest drainage, Need for hospitalization |  | Measure evaluated during entire course of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biopsy, Fine needle aspiration