Feasibility of an Electromagnetic Navigation System in a Standard Clinical Ultrasound Endoscopy Setting

Completed

• Conditions: Non-small-cell lung carcinoma; lung cancer; 10038666

• Registration Number: NL-OMON39930
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

- Candidate for non-emergency EUS
- Signed informed consent provided
- Subject above 18 years of age
- CT thorax/mediastinum available

Exclusion Criteria

- Existence of a pacemaker or Automatic Implantable Cardioverter Defribillator (AICD)
- Any subject whose medical condition implies that prolongation of the EUS procedure would have obvious adverse effects
- Obesity (Body Mass Index (BMI) > 30)
- Subjects with significant metal implants including, but not limited to, bone plates and bone screws near the mediastinum.
- Subjects with chest wall deformities (Pectus excavatum, pectus carinatum)

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the accuracy of the EMTS. This is measured as<br /><br>the orthogonal distance between the position of the US plane in which an<br /><br>anatomical landmark is visualized and the corresponding landmark on the CT<br /><br>data.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to determine the usability of the navigation system.<br /><br>This is achieved by letting the physician fill out an SUS directly after the<br /><br>EUS procedure.</p><br>