Pilot Study of the ACE System in Lung Procedures

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

To evaluate the XACT ACE Robotic System in lung procedures.

Study Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Device: XACT ACE Robotics study arm

Detailed Description

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
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Subjects undergoing procedures with the XACT ACE Robotic system.	Device: XACT ACE Robotics study arm; Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence, severity, and frequency of adverse events and device-related adverse events	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	1 hour

Collaborators and Investigators

• Sponsor: Xact Robotics Ltd.
• Investigators: Principal Investigator: Sebastian Flacke, MD, Lahey Hospital & Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): August 3, 2021
• Study Completion (Actual): August 3, 2021

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: CLIN-LUNG-01-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes