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

Sponsor
Sensome
Study ID
NCT06380361
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BioSpy System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 28, 2024
Status verified
Mar 2026
Primary completion
Apr 23, 2025
Completion
Apr 23, 2025

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: All patients will be allocated to the same study arm.
    During the bronchoscopic biopsy procedure, the study device will be entered through the bronchoscope to the level of the lesion. At lesion level, the BioSpy System sensor will make several measurements of the tumors and peripheral lung nodules and masses.

Primary Outcome Measure

The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy. [ Time Frame: During the bronchoscopy procedure, up to 79 minutes ]

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