Lung Diseases
Conditions
Brief summary
To evaluate the XACT ACE Robotic System in lung procedures.
Detailed description
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.
Interventions
DEVICEXACT ACE Robotics study arm
Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.
Sponsors
Xact Robotics Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age 2. 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. 3. Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure 4. Subject is willing to sign informed consent 5. Subject is capable of adhering to study procedures
Exclusion criteria
1. Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart 2. Subject with significant coagulopathy 3. Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study 4. Subjects who are pregnant or nursing 5. Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30 days | Incidence, severity, and frequency of adverse events and device-related adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Performance Evaluation - Clinical Accuracy | 1 hour | Percent of procedures in which the needle reached the pre-defined target based on the physician's determination and CT imaging confirmation (clinical accuracy) |
| Secondary Performance Evaluation - System Accuracy | 1 hour | The measured distance from the tip of the needle/tool to the target location at the end of the needle/tip insertion. |
Countries
United States
Outcome results
None listed