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

NCT04612985 | Withdrawn FDA Device

• 1 other identifier: CLN-002-00
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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.

Conditions

CT-guided Minimally Invasive Procedures e.g. Biopsies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• Device Usability

  At the end of each interventional procedure, approximately 1 hour

• Evaluation of Safety

  Through study completion (2 weeks)

Study Arms (1)

Procedures with XACT Robotic System

EXPERIMENTAL

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

Interventions

XACT Robotic System DEVICE

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

Procedures with XACT Robotic System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xact Robotics Ltd.: lead

Study Sites (2)

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Study Officials

• Ahava Stein

  A. Stein Regulatory Affairs Consulting Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: November 3, 2020
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)