Lesion Abnormality
Conditions
Interventions
COReKeY biopsy device
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: ASA physical status 1-3Age above 18 years A single pulmonary nodule with an indication for diagnostic evaluation following current clinical guidelines and clinical judgement. Subject is willing and able to give written informed consent for clinical investigation participation prior to the procedurePatient has solid or semi-solid pulmonary nodule(s) of =6 mm and =3 cm in largest dimension (based on pre-procedure CT scan).
Exclusion criteria
Exclusion criteria: Contra-indication for navigation bronchoscopyNot fit to undergo navigation bronchoscopyPatient is pregnantInability to consentLess than 18 years oldContra-indication for temporary interruption of the use of anticoagulant therapy with the exception of acetylsalicylic acid (acenocoumarin, warfarin, therapeutic dose of low molecular weight heparins, clopidogrel or analogs, NOAC’s)Uncontrolled pulmonary hypertensionRecent and/or uncontrolled cardiac diseaseCompromised upper airway (e.g., central airway stenosis for any reason such that endobronchial access is considered unsafe)Endobronchial visible tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this efficacy study is to assess the overall diagnostic yield of the Investigational Device in comparison to conventional biopsy tools.The overall diagnostic yield is defined as the number of times the procedure was diagnostic (either malignant or benign), relative to the total number of attempted navigation procedures. The criteria for what constitutes a diagnostic sample will be modelled after the strict definitions as described in the ATS/ACCP guidelines | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to assess specimen quality in terms of ability to perform additional molecular analysis and DNA analysis (this requires a percentage of tumor cells >30% of evaluated specimen volume with a minimum of 200 cells). | — |
Countries
Netherlands
Contacts
Public ContactJHE Kroef
Radboud Universitair Medisch Centrum
Outcome results
None listed