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

CT-guided Minimally Invasive Procedures e.g. Biopsies Clinical Trial

Official title:

Evaluation of the Safety, Effectiveness and Usability of the XACT Robotic System for Image Guided Percutaneous Lung Procedures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04612985
• Other study ID #: CLN-002-00
• Status: Withdrawn
• Phase: N/A
• Start date: September 2018
• Est. completion date: December 2019

Study information

• Verified date: October 2020
• Source: Xact Robotics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CT-guided Minimally Invasive Procedures e.g. Biopsies

Intervention

Device:
• XACT Robotic System
CT-guided Minimally Invasive Procedures e.g., Biopsies

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Xact Robotics Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device Usability	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.	At the end of each interventional procedure, approximately 1 hour
Other	Evaluation of Safety	Evaluation of safety by assessing frequency, severity and causality of device related adverse events.	Through study completion (2 weeks)
Primary	System accuracy will be determined by the measured distance from the tip of the needle/tool to the target.	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.	At the end of each interventional procedure, approximately 1 hour
Secondary	Clinical accuracy of the study will be determined by the ability of the XACT system to reach the pre-defined target in each procedure.	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.	At the end of each interventional procedure, approximately 1 hour