Evaluation of the XACT Robotic System for Image-guided Percutaneous Lung Procedures
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|ClinicalTrials.gov Identifier: NCT04612985|
Recruitment Status : Withdrawn (The IDE wasn't approved)
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|CT-guided Minimally Invasive Procedures e.g. Biopsies||Device: XACT Robotic System||Not Applicable|
This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. The study will be approved by the Institutional Review Board (IRB) at each of the participating centers prior to patient enrollment.
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Safety, Effectiveness and Usability of the XACT Robotic System for Image Guided Percutaneous Lung Procedures|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: 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.
Device: XACT Robotic System
CT-guided Minimally Invasive Procedures e.g., Biopsies
- System accuracy will be determined by the measured distance from the tip of the needle/tool to the target. [ Time Frame: At the end of each interventional procedure, approximately 1 hour ]The primary endpoint of the study is to evaluate the system accuracy of the XACT System. System accuracy of the study will be determined by the measured distance from the tip of the needle/tool to the target, once the XACT Robot reaches the pre-defined target.
- Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure. [ Time Frame: At the end of each interventional procedure, approximately 1 hour ]The secondary endpoint of the study is to evaluate the clinical accuracy of the XACT system. Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure.
- Device Usability [ Time Frame: At the end of each interventional procedure, approximately 1 hour ]Usability of the XACT device performance in the hands of users will be evaluated using a rating scale for assessing the ease of device performance.
- Evaluation of Safety [ Time Frame: Through study completion (2 weeks) ]Evaluation of safety by assessing frequency, severity and causality of device related adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612985
|United States, Massachusetts|
|Lahey Hospital and Medical Center|
|Burlington, Massachusetts, United States, 01805|
|Hadassah Medical Center|
|Jerusalem, Israel, 91120|
|Study Director:||Ahava Stein||A. Stein - Regulatory Affairs Consulting Ltd.|