Pilot Study of the ACE System in Lung Procedures

• Sponsor: Xact Robotics Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04651517
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

To evaluate the XACT ACE Robotic System in lung procedures.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases	Device: XACT ACE Robotics study arm	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung
• Actual Study Start Date: Mar 15, 2021
• Actual Primary Completion Date: Aug 3, 2021
• Actual Study Completion Date: Aug 3, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Adverse Events [30 days]

   Incidence, severity, and frequency of adverse events and device-related adverse events

Secondary Outcome Measures

1. 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)

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lahey Hospital and Medical Center	Burlington	Massachusetts	United States	01805

Sponsors and Collaborators

• Xact Robotics Ltd.

Investigators

• Principal Investigator: Sebastian Flacke, MD, Lahey Hospital & Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xact Robotics Ltd.
• ClinicalTrials.gov Identifier: NCT04651517
• Other Study ID Numbers: CLIN-LUNG-01-2020
• First Posted: Dec 3, 2020
• Last Update Posted: Aug 9, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Lung Diseases

Study Results

No Results Posted as of Aug 9, 2021