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Evaluation of the XACT Robotic System for Image-guided Percutaneous Lung Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04612985
Recruitment Status : Withdrawn (The IDE wasn't approved)
First Posted : November 3, 2020
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Xact Robotics Ltd.

Tracking Information
First Submitted Date  ICMJE February 14, 2018
First Posted Date  ICMJE November 3, 2020
Last Update Posted Date November 3, 2020
Estimated Study Start Date  ICMJE September 2018
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2020)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 30, 2020)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluation of the XACT Robotic System for Image-guided Percutaneous Lung Procedures
Official Title  ICMJE Evaluation of the Safety, Effectiveness and Usability of the XACT Robotic System for Image Guided Percutaneous Lung Procedures
Brief Summary This is a prospective, single arm study, to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite. eg. core, biopsy, will participate in the study. System and clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CT-guided Minimally Invasive Procedures e.g. Biopsies
Intervention  ICMJE Device: XACT Robotic System
CT-guided Minimally Invasive Procedures e.g., Biopsies
Study Arms  ICMJE 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.
Intervention: Device: XACT Robotic System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 30, 2020)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women over 18 years of age
  • 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:

  • Subjects in whom the target is written 1 cm of a major blood vessel or major nerve.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04612985
Other Study ID Numbers  ICMJE CLN-002-00
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xact Robotics Ltd.
Study Sponsor  ICMJE Xact Robotics Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ahava Stein A. Stein - Regulatory Affairs Consulting Ltd.
PRS Account Xact Robotics Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP