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

NCT03008603 | Completed FDA Device

• 1 other identifier: CLN-001-00
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

Brief Summary

This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite, e.g., core biopsy, will participate in the summary. Clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.

Conditions

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

Keywords

CT-guided minimally invasive procedures; Robot

Outcome Measures

Primary Outcomes (1)

• The primary 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.

  End of procedure

Secondary Outcomes (1)

• The secondary endpoint of the study is to evaluate the usability of the XACT system under actual use clinical conditions.

  End of procedure

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  End of procedure

Study Arms (1)

Procedures with XACT Robotic System

EXPERIMENTAL

CT-guided minimally invasive percutaneous procedures using the XACT Robotics system

Device: XACT Robotic System

Interventions

XACT Robotic System DEVICE

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 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.

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 lesions in the central and peripheral nervous system and the spine.
• 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 & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

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: December 28, 2016
• First Posted: January 2, 2017
• Study Start: September 4, 2018
• Primary Completion: February 16, 2021
• Study Completion: February 16, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); US (1)