Tumors
Conditions
Keywords
CT-guided percutaneous procedure, Percutaneous biopsy, XACT ACE Robotic System
Brief summary
Compile real world data on the use of the XACT ACE Robotic System
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.
Interventions
DEVICEHands-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.
Sponsors
Xact Robotics Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
1. ≥ 18 years of age 2. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite 3. Subject is willing to sign informed consent for the purposes of data collection
Exclusion criteria
1\. No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactMark Macedo
Outcome results
None listed