InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
Sensome
30 participants
Mar 28, 2024
INTERVENTIONAL
Conditions
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 Criteria6
- Age \> 18 years
- Subjects with lesions eligible for lung biopsy under general anesthesia.
- Lesion localization:
- Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or
- 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.
- Written Informed Consent to participate in the study.
Exclusion Criteria5
- Target lesion \<10 mm for central and \<20 mm for peripheral lesions (as determined on previous imaging)
- Contra-indication to bronchoscopy procedures
- Contra-indication to general anesthesia
- Any subject that is, according to the discretion of the investigator, not eligible for study participation
- Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
Interventions
One arm only - in all eligible study patients, the study device will be used. In patients with suspicion of lung cancer a bronchoscope will be inserted to navigate to the lesion where a biopsy sample will be taken for histology analysis. In the current trial, the device will be used to perform electrophysiological measurements in the lesion during bronchoscopic biopsy procedure.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06380361