XACT ACE Observational Registry

Last updated: October 19, 2022
Sponsor: Xact Robotics Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

N/A

Clinical Study ID

NCT04950959
CLIN-REG-01-2020
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥ 18 years of age
  2. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in theinterventional radiology suite
  3. Subject is willing to sign informed consent for the purposes of data collection

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 500
Study Start date:
October 01, 2021
Estimated Completion Date:
August 01, 2026

Study Description

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.

Connect with a study center

  • Sarasota Interventional Radiology

    Sarasota, Florida 34240
    United States

    Site Not Available

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts 01805
    United States

    Active - Recruiting

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