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NCT Number: NCT04950959

XACT ACE Observational Registry

Compile real world data on the use of the XACT ACE Robotic System

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Key information

Conditions

Tumors Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location status: Recruiting

Location contact

Nanette Matrullo

CONTACT

[email protected]

781-744-2906

Sebastian Flacke, MD

PRINCIPAL_INVESTIGATOR

About this study

The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures.

The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events.

Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥ 18 years of age
  • Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite
  • Subject is willing to sign informed consent for the purposes of data collection

Exclusion criteria

  • No exclusion criteria other than listed in the product Instructions for Use (IFU)

Treatment and study plan

Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T

Device

The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. The XACT ACE Robotic System uses a computerized quantitative guidance system, which provides real-time, accurate needle guidance, including advancement and steering of the needle from the entry point on the subject's body to the target point within the body.

Primary outcomes

  1. Proportion of successful procedures

    Time frame: 1 hour

    To evaluate the proportion of procedures in which the instrument reached the pre-defined target based on the physician's determination and CT imaging confirmation.

  2. System accuracy

    Time frame: 1 hour

    To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the end of the instrument insertion.

  3. Assessment of Safety

    Time frame: 2 hours post-procedure

    Incidence of intra- and post-procedural events

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Macedo

CONTACT

[email protected]

5082076505

Sponsors and collaborators

Lead sponsor

Xact Robotics Ltd.

Industry

Registry information

Official study title

Observational Post-Market Study of the XACT ACE Robotic System

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2021
Registry last updated
Oct 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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