XACT ACE Observational Registry

Observational Post-Market Study of the XACT ACE Robotic System

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Mark Macedo; Phone Number: 5082076505; Email: mark.macedo@xactrobotics.com

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Recruiting
      • Lahey Hospital and Medical Center
      • Contact: Nanette Matrullo; Phone Number: 781-744-2906; Email: nanette.matrullo@lahey.org
      • Principal Investigator: Sebastian Flacke, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects undergoing CT guided, minimally invasive percutaneous procedures in an interventional radiology setting.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xact Robotics Ltd.
• Investigators: Study Director: Mark Macedo, XACT Robotics

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Anticipated): July 1, 2026
• Study Completion (Anticipated): August 1, 2026

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous biopsy; CT-guided percutaneous procedure; XACT ACE Robotic System
• Other Study ID Numbers: CLIN-REG-01-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No