Navigation Endobronchial Ultrasound

NCT04553809 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-14

No results posted yet for this study

Summary

Lung cancer is the primary cause of cancer related deaths in Denmark. In order to improve the prognosis diagnosis in earlier stages are needed. This will however require improved sampling techniques from very small lung lesions.

One method involves the use of a radial ultrasound probe inserted in the working channel of the bronchoscope, to more accurately identify the lung lesions before sampling them (rEBUS). The other method involves the use of electromagnetic navigation bronchoscopy (ENB) to guide the operator to the lung lesion.

This study aims to determine whether a combination of rEBUS and ENB is superior to ENB alone in biopsy sampling. The study will be conducted as a non-blinded RCT. Furthermore, we will make an estimate of the hospital costs of the entire diagnostic work up for lung cancer when combining ENB and rEBUS compared to ENB alone.

Conditions

Interventions

PROCEDURE

ENB

ENB for biopsy sampling of peripheral lung lesion

PROCEDURE

ENB in combination with rEBUS

The combination of ENB and rEBUS for biopsy sampling of peripheral lung lesions

Sponsors & Collaborators

  • Amanda Dandanell Juul

    lead OTHER

Principal Investigators

  • Amanda Dandanell Juul, MD · Dept. of Respiratory Medicine, Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-12
Primary Completion
2024-08-30
Completion
2025-03-01

Countries

  • Denmark

Study Locations

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Entities

Diseases

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 NCT04553809 on ClinicalTrials.gov