Pilot Study of the ACE System in Lung Procedures

Study Overview
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Brief Summary
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To evaluate the XACT ACE Robotic System in lung procedures.

Detailed Description
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The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous lung procedures. The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. This study will evaluate safety and accuracy of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures of the lung in the interventional radiology suite.

Official Title
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Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung

Conditions
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Lung Diseases

Intervention / Treatment
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* Device: XACT ACE Robotics study arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc. Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure Subject is willing to sign informed consent Subject is capable of adhering to study procedures Exclusion Criteria: Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart Subject with significant coagulopathy Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study Subjects who are pregnant or nursing Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)

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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Subjects undergoing procedures with the XACT ACE Robotic system. | Device: XACT ACE Robotics study arm<br>* Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence, severity, and frequency of adverse events and device-related adverse events | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Performance Evaluation - Clinical Accuracy | Percent of procedures in which the needle reached the pre-defined target based on the physician's determination and CT imaging confirmation (clinical accuracy) | 1 hour | 
| Secondary Performance Evaluation - System Accuracy | The measured distance from the tip of the needle/tool to the target location at the end of the needle/tip insertion. | 1 hour |