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Confocal Laser Endomicroscopy VERification

NCT06079970 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-04-07

No results posted yet for this study

Summary

The goal of this multi-center randomized clinical trial is to evaluate the added value of needle based confocal laser endomicroscopy (nCLE)-imaging to regular diagnostic bronchoscopic peripheral lung lesion analysis on the diagnostic yield in patients with peripheral pulmonary nodules suspect for malignancy.

The main question\[s\] it aims to answer are:

To determine if the addition of nCLE-imaging to conventional diagnostic bronchoscopic peripheral lung lesion analysis results in an improved diagnostic yield (defined as the proportion of patients in whom the bronchoscopic procedure results in a definitive diagnosis out of the total number of patients that have received the diagnostic bronchoscopic procedure).

Participants will undergo diagnostic bronchoscopy either with or without the addition of nCLE imaging before each TBNA. Based on the feedback of the CLE images on (in)correct placement of the needle, the needle might be repositioned before sampling. Comparison between the diagnostic yield of these groups will be done including subgroup analysis.

Conditions

  • Lung Cancer
  • Lung Neoplasm Malignant
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasm of Lung

Interventions

DEVICE

Neelde Based Confocal Laser Endomicroscopy

Confocal microscopy through the TBNA needle before tissue sampling using the Cellvizio system and AQ flex probe (Mauna Kea Technologies)

PROCEDURE

Conventional diagnostic bronchoscopy

Conventional diagnostic bronchoscopy with r-EBUS and optionally fluoroscopy AND/OR EMN AND/OR VB AND/OR ultrathin scope

Sponsors & Collaborators

  • Mauna Kea Technologies

    collaborator INDUSTRY

  • Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)

    lead OTHER

Principal Investigators

  • Jouke Annema, Prof. dr. · Amsterdam UMC

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Czechia
  • Greece
  • Netherlands

Study Locations

More Related Trials

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 NCT06079970 on ClinicalTrials.gov