Status:
COMPLETED
CT-controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Augmented Fluoroscopy Bronchoscopic Navigation Based Diagnostic Yield
Lead Sponsor:
Radboud University Medical Center
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
In this exploratory adaptive clinical trial the investigators will examine the diagnostic yield of a combination of commercially available imaging and navigation techniques for reaching peripheral lun...
Detailed Description
Lung cancer is one of the leading most frequent types of cancer and is the most lethal malignancy in the Netherlands. Mortality is high due to its advanced stage disease at diagnosis. To improve survi...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- ASA physical status 1-3.
- Age 18 years or older.
- A pulmonary lesion (i.e. a focal, rounded opacity mostly surrounded by aerated lung or a ground glass opacity or part- or sub-solid lesion) with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.
Exclusion
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Bleeding disorders.
- Less than 18 years old.
- Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines, clopidrogel, analogs, or, NOAC's).
- Known allergy for lidocaine.
- Uncontrolled pulmonary hypertension.
- Recent and/or uncontrolled cardiac disease.
- Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any reason such that endobronchial access is considered unsafe).
- ASA classification greater than or equal to 4 (unfit for performing non-surgical biopsy).
- Pregnancy.
- Inability to consent.
Key Trial Info
Start Date :
December 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03274609
Start Date
December 21 2017
End Date
November 1 2019
Last Update
December 17 2019
Active Locations (1)
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1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA