Pilot Study of the ACE System in Lung Procedures

Xact Robotics Ltd.20 enrolled

Overview

To evaluate the XACT ACE Robotic System in lung procedures.

The XACT ACE Robotic System is a user-controlled positioning system intended to assist in the planning and advancement of an instrument during Computed Tomography (CT) guided percutaneous lung procedures. 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. This study will evaluate safety and accuracy of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures of the lung in the interventional radiology suite.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Lung Diseases

Interventions

XACT ACE Robotics study armDEVICE

Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years of age 2. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc. 3. Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure 4. Subject is willing to sign informed consent 5. Subject is capable of adhering to study procedures Exclusion Criteria: 1. Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart 2. Subject with significant coagulopathy 3. Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study 4. Subjects who are pregnant or nursing 5. Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)

Locations (1)

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Outcomes

Primary Outcomes

Adverse Events

Incidence, severity, and frequency of adverse events and device-related adverse events

Time frame: 30 days

Secondary Outcomes

Secondary Performance Evaluation - Clinical Accuracy

Percent of procedures in which the needle reached the pre-defined target based on the physician's determination and CT imaging confirmation (clinical accuracy)

Time frame: 1 hour

Secondary Performance Evaluation - System Accuracy

The measured distance from the tip of the needle/tool to the target location at the end of the needle/tip insertion.

Time frame: 1 hour

Data from ClinicalTrials.gov

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