XACT ACE Observational Registry
Study Details
Study Description
Brief Summary
Compile real world data on the use of the XACT ACE Robotic System
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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All subjects 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
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.
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Outcome Measures
Primary Outcome Measures
- Proportion of successful procedures [1 hour]
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.
- System accuracy [1 hour]
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.
- Assessment of Safety [2 hours post-procedure]
Incidence of intra- and post-procedural events
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥ 18 years of age
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Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite
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Subject is willing to sign informed consent for the purposes of data collection
Exclusion Criteria:
- No exclusion criteria other than listed in the product Instructions for Use (IFU)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Sarasota Interventional Radiology | Sarasota | Florida | United States | 34240 |
Sponsors and Collaborators
- Xact Robotics Ltd.
Investigators
- Study Director: Mark Macedo, XACT Robotics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLIN-REG-01-2020