Pilot Study of the ACE System in Lung Procedures

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651517
• Other study ID #: CLIN-LUNG-01-2020
• Status: Completed
• Phase: N/A
• Start date: March 15, 2021
• Est. completion date: August 3, 2021

Study information

• Verified date: August 2021
• Source: Xact Robotics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the XACT ACE Robotic System in lung procedures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• XACT ACE Robotics study arm
Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Xact Robotics Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence, severity, and frequency of adverse events and device-related adverse events	30 days
Secondary	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	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