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NCT04950959Recruiting

XACT ACE Observational Registry

Xact Robotics Ltd.

Start Date

10/1/2021

Completion Date

8/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

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

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Conditions

Tumors

Locations

Lahey Hospital and Medical Center

Burlington, Massachusetts 01805

United States