Back to resultsPilot Study of the ACE System in Lung Procedures
Primary Purpose
Lung Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
XACT ACE Robotics study arm
Sponsored by
About this trial
This is an interventional other trial for Lung Diseases
Eligibility Criteria
Inclusion Criteria:
- 18 years of age
- 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.
- Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure
- Subject is willing to sign informed consent
- Subject is capable of adhering to study procedures
Exclusion Criteria:
- Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart
- Subject with significant coagulopathy
- Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study
- Subjects who are pregnant or nursing
- Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)
Sites / Locations
- Lahey Hospital and Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study arm
Arm Description
Subjects undergoing procedures with the XACT ACE Robotic system.
Outcomes
Primary Outcome Measures
Adverse Events
Incidence, severity, and frequency of adverse events and device-related adverse events
Secondary Outcome Measures
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04651517
Brief Title
Pilot Study of the ACE System in Lung Procedures
Official Title
Pilot Study of the XACT Robotics ACE System for Image Guided Percutaneous Procedures in the Lung
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2021 (Actual)
Primary Completion Date
August 3, 2021 (Actual)
Study Completion Date
August 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xact Robotics Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Subjects 18 years of age or older who are undergoing CT guided, minimally invasive percutaneous procedures of the lung.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study arm
Arm Type
Experimental
Arm Description
Subjects undergoing procedures with the XACT ACE Robotic system.
Intervention Type
Device
Intervention Name(s)
XACT ACE Robotics study arm
Intervention Description
Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence, severity, and frequency of adverse events and device-related adverse events
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Secondary Performance Evaluation - Clinical Accuracy
Description
Percent of procedures in which the needle reached the pre-defined target based on the physician's determination and CT imaging confirmation (clinical accuracy)
Time Frame
1 hour
Title
Secondary Performance Evaluation - System Accuracy
Description
The measured distance from the tip of the needle/tool to the target location at the end of the needle/tip insertion.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age
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.
Following planning and registration CT scans, subject is found eligible to undergo CT-guided, minimally invasive percutaneous procedure
Subject is willing to sign informed consent
Subject is capable of adhering to study procedures
Exclusion Criteria:
Subjects in whom the target is within 1 cm of a major blood vessel, major nerve or heart
Subject with significant coagulopathy
Subject with preexisting or unstable medical condition(s), which in the opinion of the investigator, might interfere with the conduct of the study
Subjects who are pregnant or nursing
Following planning and registration CT scans, required clinical trajectory to target is beyond system workspace limits (e.g., entry angle is too sharp)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Flacke, MD
Organizational Affiliation
Lahey Hospital & Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study of the ACE System in Lung Procedures
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