RecruitingNot ApplicableNCT06380361

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


Sponsor

Sensome

Enrollment

30 participants

Start Date

Mar 28, 2024

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new smart probe that uses electrical signals (impedance technology) to help doctors better identify and characterize lung lesions during a bronchoscopy (a procedure where a camera is passed into the airways). The goal is to improve accuracy when collecting tissue samples from lung nodules. **You may be eligible if...** - You are over 18 - You have a lung lesion that requires a biopsy under general anesthesia - Your lesion is large enough to target (at least 10 mm for central lesions or 20 mm for peripheral lesions) - You are willing and able to give informed consent **You may NOT be eligible if...** - Your lesion is smaller than the required size - You cannot have a bronchoscopy or general anesthesia safely Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBioSpy System

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)

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Marie-Lannelongue Hospital

Le Plessis-Robinson, France

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NCT06380361


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