XACT ACE Observational Registry

Sponsor
Xact Robotics Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04950959
Collaborator
(none)
500
1
58
8.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Observational Post-Market Study of the XACT ACE Robotic System
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Aug 1, 2026

Arms and Interventions

Arm Intervention/Treatment
All subjects

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

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

Outcome Measures

Primary Outcome Measures

  1. Proportion of successful procedures [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 [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 [2 hours post-procedure]

    Incidence of intra- and post-procedural events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sarasota Interventional Radiology Sarasota Florida United States 34240

Sponsors and Collaborators

  • Xact Robotics Ltd.

Investigators

  • Study Director: Mark Macedo, XACT Robotics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xact Robotics Ltd.
ClinicalTrials.gov Identifier:
NCT04950959
Other Study ID Numbers:
  • CLIN-REG-01-2020
First Posted:
Jul 6, 2021
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Xact Robotics Ltd.

Study Results

No Results Posted as of Oct 28, 2021