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Clinical Trials/NL-OMON53986
NL-OMON53986
Recruiting
Not Applicable

CLE-guided bronchoscopy for peripheral lung cancer diagnosis: a Randomized Controlled Trial - Confocal Laser Endomicroscopy Verification (CLEVER)

Academisch Medisch Centrum0 sites45 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral lung cancer
Sponsor
Academisch Medisch Centrum
Enrollment
45
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • \>\=18 years of age
  • Suspected malignant peripheral lung lesion with an indication for a
  • bronchoscopic diagnostic work\-up
  • Solid part of the lesion must be \>10 mm
  • Largest dimension of lesion size on CT equal to or less than 30 mm
  • Bronchus sign on pre\-procedural CT or estimated confidence for successful
  • navigation to the nodule resulting in a r\-EBUS signal
  • Ability to understand and willingness to sign a written informed consent

Exclusion Criteria

  • Inability or non\-willingness to provide informed consent
  • Patients with an endobronchial visible lung tumor on bronchoscopic inspection
  • Patients in which the target lesion is within reach of the linear EBUS scope
  • Failure to comply with the study protocol
  • Patients with known allergy for fluorescein or risk factors for an allergic
  • Pregnant or breastfeeding women
  • Patients with hemodynamic instability
  • Patients with refractory hypoxemia
  • Patients with a therapeutic anticoagulant that cannot be held for an
  • appropriate interval before the procedure

Outcomes

Primary Outcomes

Not specified

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