Evaluation of the XACT Robotic System for Image-guided Percutaneous Lung Procedures
NCT ID: NCT04612985
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2018-09-30
2019-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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., and willing to sign an informed consent document will be screened for compliance with the study inclusion and exclusion criteria.
A total of thirty (41) subjects will be enrolled in the study at 5 medical centers. The intention is to recruit subjects, which will cover a variety of CT-guided interventional lung procedures and a variety of different procedural tools that may be used with the device. Investigators will screen patients based on the inclusion/exclusion criteria described below and the subjects' demographic, general medical history, medical condition/indication, coagulation factors, concomitant medications and vital signs will be obtained.
The system accuracy will be the primary efficacy endpoint and is defined as the measured distance from the tip of the needle/tool to the target, once the XACT robot reaches the pre-defined target .
Clinical accuracy will be the secondary efficacy endpoint and is defined as the ability to place the instrument or procedural tool at a location suitable for the planned intervention. The investigator will review the final instrument position on the post-placement CT images to determine if the pre-operative planned target was reached. This information will be used to calculate success rate.
Additionally, the usability of the XACT device will be evaluated using a rating scale by assessing the ease of device setup, device operation, pre-operative planning, robot positioning, guiding and needle advancement. The total time of the procedure will be recorded, as will the number of CT scans performed and the radiation dose (DLP and CTDI).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Procedures with XACT Robotic System
Device: XACT Robotic System The XACT device is a real-time, CT image guided, 3-dimensional robotic system. The XACT device is intended for use as an image guided positioning and steering system for insertion of clinical tools, such as biopsy needles, ablation needles, etc., during minimally invasive percutaneous lung procedures. The system is defined to guide (i.e., position and steer) the tool according to a predefined trajectory following a registration process between the device's coordinate system and real-time CT images.
XACT Robotic System
CT-guided Minimally Invasive Procedures e.g., Biopsies
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
XACT Robotic System
CT-guided Minimally Invasive Procedures e.g., Biopsies
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite, e.g., core biopsy, fine needle aspiration (FNA), tumor ablation, etc.
* Subject is capable and willing to provide informed consent.
* Subject is capable and willing to adhere to the study procedures.
Exclusion Criteria
* Subject with lesion in the central and peripheral nervous system and the spine.
* Subjects in whom the target is within 1 cm of a major blood vessel or major nerve.
* Subject with significant coagulopathy
* Subjects with a preexisting conditions, which, in the opinion of the investigator, may interfere with the conduct of the study.
* Subjects with an unstable medical condition, e.g. unstable hypertension, unstable cardiac disease, etc.
* Subjects who are uncooperative or cannot follow instructions.
* Subjects with a mental state that may preclude completion of the study procedure.
* Female subjects who are pregnant or nursing.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Xact Robotics Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ahava Stein
Role: STUDY_DIRECTOR
A. Stein Regulatory Affairs Consulting Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Hadassah Medical Center
Jerusalem, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLN-002-00
Identifier Type: -
Identifier Source: org_study_id