CompletedNot Applicable

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

Australia, France30 participantsStarted 2024-03-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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)

What they're measuring

The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy.

Timeframe: During the bronchoscopy procedure, up to 79 minutes

Trial details

NCT IDNCT06380361

SponsorSensome

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-23

Results submitted2026-03-03

View on ClinicalTrials.gov More Lung Cancer trials