Evaluation of the Safety, Effectiveness & Usability of the XACT Robotic System for Image Guided Percutaneous Procedures

This is a prospective, single-arm study is to evaluate the safety, effectiveness and
usability of the XACT device. The study will be approved by the Institutional Review Board
(IRB) at each of the participating centers prior to patient enrollment.

Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the
interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor
ablation, etc., and willing to sign an informed consent document will be screened for
compliance with the study inclusion and exclusion criteria.

A total of thirty (85) subjects will be enrolled in the study at 5 medical centers. The
intention is to recruit subjects, which will cover a variety of CT-guided interventional
procedures and a variety of different procedural tools that may be used with the device.
Investigators will screen patients based on the inclusion/exclusion criteria described below
and the subjects' demographic, general medical history, medical condition/indication,
coagulation factors, concomitant medications and vital signs will be obtained.

Clinical accuracy will be the primary efficacy endpoint and is defined as the ability to
place the instrument or procedural tool at a location suitable for the planned intervention.
The investigator will review the final instrument position on the post-placement CT images to
determine if the pre-operative planned target was reached. This information will be used to
calculate success rate.

Additionally, the usability of the XACT device will be evaluated using a rating scale by
assessing the ease of device setup, device operation, pre-operative planning, robot
positioning, guiding and needle advancement. The total time of the procedure will be
recorded, as will the number of CT scans performed and the radiation dose (DLP and CTDI). The
distance from the tip of the needle/tool to the target, once the XACT robot reaches the
pre-defined target will be measured in order to determine system accuracy in quantitative
terms using the system tools.

Inclusion Criteria:

- Men and women over 18 years of age

- Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the
interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor
ablation, etc.

- Subject is capable and willing to provide informed consent.

- Subject is capable and willing to adhere to the study procedures

Exclusion Criteria:

- Subjects in whom the target is written 1 cm of a major blood vessel or major nerve.

- Subject with lesions in the central and peripheral nervous system and the spine.

- Subject with significant coagulopathy

- Subjects with a preexisting conditions, which, in the opinion of the investigator, may
interfere with the conduct of the study

- Subjects with an unstable medical condition, e.g. unstable hypertension, unstable
cardiac disease, etc.

- Subjects who are uncooperative or cannot follow instructions

- Subjects with a mental state that may preclude completion of the study procedure

- Female subjects who are pregnant or nursing