InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology

Summary

The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses.

Eligibility

Inclusion Criteria:

1. Age \> 18 years
2. Subjects with lesions eligible for lung biopsy under general anesthesia.
3. Lesion localization:

   1. Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or
   2. Peripheral lesions ≥ 20 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or ultrasound analysis (RP EBUS with central localization of the ultrasound probe) during the procedure.
4. Written Informed Consent to participate in the study.

Exclusion Criteria:

1. Target lesion \<10 mm for central and \<20 mm for peripheral lesions (as determined on previous imaging)
2. Contra-indication to bronchoscopy procedures
3. Contra-indication to general anesthesia
4. Any subject that is, according to the discretion of the investigator, not eligible for study participation
5. Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)

Conditions2

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