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NCT04950959 | RECRUITING | Tumors


XACT ACE Observational Registry
Sponsor:

Xact Robotics Ltd.

Brief Summary:

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

Condition or disease

Tumor

Intervention/treatment

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

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 500 participants
Official Title : Observational Post-Market Study of the XACT ACE Robotic System
Actual Study Start Date : 2021-10-01
Estimated Primary Completion Date : 2026-07-01
Estimated Study Completion Date : 2026-08-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Criteria
Inclusion Criteria
  • 1. ≥ 18 years of age
  • 2. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite
  • 3. Subject is willing to sign informed consent for the purposes of data collection
Exclusion Criteria
  • 1\. No exclusion criteria other than listed in the product Instructions for Use (IFU)

XACT ACE Observational Registry

Location Details

NCT04950959


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Massachusetts

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States, 01805

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