Pilot Study of the ACE System in Lung Procedures

Not Applicable

Completed

• Conditions: Lung Diseases
• Interventions: Device: XACT ACE Robotics study arm

• Registration Number: NCT04651517
• Lead Sponsor: Xact Robotics Ltd.

Brief Summary

To evaluate the XACT ACE Robotic System in lung procedures.

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 Timeline

• Study First Submitted: 2020-11-17
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-03
• Study Start: 2021-03-15
• Status Verified: 2021-08
• Primary Completion: 2021-08-03
• Study Completion: 2021-08-03
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study arm	XACT ACE Robotics study arm	Subjects undergoing procedures with the XACT ACE Robotic system.

Primary Outcome Measures

Name	Time	Method
Adverse Events	30 days	Incidence, severity, and frequency of adverse events and device-related adverse events

Secondary Outcome Measures

Name	Time	Method
Secondary Performance Evaluation - Clinical Accuracy	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)
Secondary Performance Evaluation - System Accuracy	1 hour	The measured distance from the tip of the needle/tool to the target location at the end of the needle/tip insertion.

Trial Locations

Locations (1)

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States