NCT04950959

XACT ACE Observational Registry

Observational Post-Market Study of the XACT ACE Robotic System

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Xact Robotics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Tumors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2026-07-01
• Completion: 2026-08-01
• First posted: 2021-07-06
• Last updated: 2022-10-21

Locations

1 site across 1 country: United States