XACT ACE Observational Registry

Recruiting

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

• Registration Number: NCT04950959
• Lead Sponsor: Xact Robotics Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-06-25
• Study First Posted: 2021-07-06
• Study Start: 2021-10-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-19
• Last Update Posted: 2022-10-21
• Primary Completion: 2026-07-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All subjects	Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T	Subjects undergoing CT-guided, minimally invasive percutaneous procedures in an interventional radiology setting

Primary Outcome Measures

Name	Time	Method
Proportion of successful procedures	1 hour	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.
Assessment of Safety	2 hours post-procedure	Incidence of intra- and post-procedural events
System accuracy	1 hour	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.

Trial Locations

Locations (1)

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States