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OpenTrials
Completed

NCT Number: NCT04651517

Pilot Study of the ACE System in Lung Procedures

To evaluate the XACT ACE Robotic System in lung procedures.

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age
  • 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.
  • Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure
  • Subject is willing to sign informed consent
  • Subject is capable of adhering to study procedures

Exclusion criteria

  • Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart
  • Subject with significant coagulopathy
  • Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study
  • Subjects who are pregnant or nursing
  • Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)

Treatment and study plan

XACT ACE Robotics study arm

Device

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

Primary outcomes

  1. Adverse Events

    Time frame: 30 days

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

Secondary outcomes

  1. Secondary Performance Evaluation - Clinical Accuracy

    Time frame: 1 hour

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

  2. Secondary Performance Evaluation - System Accuracy

    Time frame: 1 hour

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

Sponsors and collaborators

Lead sponsor

Xact Robotics Ltd.

Industry

Registry information

Official study title

Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2020
Registry last updated
Aug 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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