XACT ACE Observational Registry

Purpose

Compile real world data on the use of the XACT ACE Robotic System

Condition

  • Tumors

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 exclusion criteria other than listed in the product Instructions for Use (IFU)

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
Contact:
Nanette Matrullo
781-744-2906
nanette.matrullo@lahey.org

More Details

Status
Recruiting
Sponsor
Xact Robotics Ltd.

Study Contact

Mark Macedo
5082076505
mark.macedo@xactrobotics.com

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.