N/A
N=30
InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT06380361 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy. — 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- BioSpy System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sensome
- Primary completion
- Apr 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy. |
26 | — |
| SECONDARY The Ability of BioSpy System to Differentiate the Lesion From Healthy Tissue |
80.9; 88.5; 71.4 | — |
| SECONDARY The Ability of BioSpy System to Differentiate Various Lesion Types |
78.7; 78.3; 79.2 | — |
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 Criteria
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)
Data sourced from ClinicalTrials.gov (NCT06380361). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.