XACT ACE Observational Registry

Study Overview
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Brief Summary
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Compile real world data on the use of the XACT ACE Robotic System

Detailed Description
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The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures. The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events. Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.

Official Title
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Observational Post-Market Study of the XACT ACE Robotic System

Conditions
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Tumors

Intervention / Treatment
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* Device: Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T


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 procedures in the interventional radiology suite Subject is willing to sign informed consent for the purposes of data collection Exclusion Criteria: 1. No exclusion criteria other than listed in the product Instructions for Use (IFU)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All subjects<br>Subjects undergoing CT-guided, minimally invasive percutaneous procedures in an interventional radiology setting | Device: Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T<br>* 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. The XACT ACE Robotic System uses a computerized quantitative guidance system, which provides real-time, accurate needle guidance, including advancement and steering of the needle from the entry point on the subject's body to the target point within the body.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of successful procedures | To evaluate the proportion of procedures in which the instrument reached the pre-defined target based on the physician's determination and CT imaging confirmation. | 1 hour | 
| System accuracy | To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the end of the instrument insertion. | 1 hour | 
| Assessment of Safety | Incidence of intra- and post-procedural events | 2 hours post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT-guided percutaneous procedure, Percutaneous biopsy, XACT ACE Robotic System