XACT ACE Observational Registry

XACT Robotics

Status: Enrolling

Conditions: Tumors

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

Study type: Observational

Funder types: Industry

Identifiers

NCT04950959

CLIN-REG-01-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

500 participants in 1 patient group

All subjects

Description:

Subjects undergoing CT-guided, minimally invasive percutaneous procedures in an interventional radiology setting

Treatment:

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