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Evaluation of the XACT Robotic System for Image-guided Percutaneous Lung Procedures

NCT04612985 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-11-03

No results posted yet for this study

Summary

This is a prospective, single arm study, to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous lung procedures in the interventional radiology suite. eg. core, biopsy, will participate in the study. System and clinical accuracy will be the primary efficacy endpoint. Usability and safety will also be evaluated.

Conditions

  • CT-guided Minimally Invasive Procedures e.g. Biopsies

Interventions

DEVICE

XACT Robotic System

CT-guided Minimally Invasive Procedures e.g., Biopsies

Sponsors & Collaborators

  • Xact Robotics Ltd.

    lead INDUSTRY

Principal Investigators

  • Ahava Stein · A. Stein Regulatory Affairs Consulting Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-09-30
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04612985 on ClinicalTrials.gov