Pilot Study of the ACE System in Lung Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2021-08-03

Brief Summary

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To evaluate the XACT ACE Robotic System in lung procedures.

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Detailed Description

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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.

Conditions

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Lung Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Study arm

Subjects undergoing procedures with the XACT ACE Robotic system.

Group Type EXPERIMENTAL

XACT ACE Robotics study arm

Intervention Type DEVICE

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

Interventions

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XACT ACE Robotics study arm

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No