Pilot Study of the ACE System in Lung Procedures

XACT Robotics

Status: Completed

Conditions: Lung Diseases

Treatments: Device: XACT ACE Robotics study arm

Study type: Interventional

Funder types: Industry

Identifiers

NCT04651517

CLIN-LUNG-01-2020

Details and patient eligibility

About

To evaluate the XACT ACE Robotic System in lung procedures.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Study arm

Experimental group

Description:

Subjects undergoing procedures with the XACT ACE Robotic system.

Treatment:

Device: XACT ACE Robotics study arm