XACT ACE Observational Registry

Tumors Clinical Trial

Official title:

Observational Post-Market Study of the XACT ACE Robotic System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950959
• Other study ID #: CLIN-REG-01-2020
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: October 2022
• Source: Xact Robotics Ltd.
• Contact: Mark Macedo
• Phone: 5082076505
• Email: mark.macedo[@]xactrobotics.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: August 1, 2026
• Est. primary completion date: July 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tumors

Intervention

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.

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Xact Robotics Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Assessment of Safety	Incidence of intra- and post-procedural events	2 hours post-procedure