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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON39930
Enrollment
5
Registered
2013-06-06
Start date
2013-06-13
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell lung carcinoma

Interventions

None listed

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
The primary study parameter is the accuracy of the EMTS. This is measured as the orthogonal distance between the position of the US plane in which an anatomical landmark is visualized and the corresponding landmark on the CT data.

Secondary

MeasureTime frame
The secondary objective is to determine the usability of the navigation system. This is achieved by letting the physician fill out an SUS directly after the EUS procedure.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)