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

RECRUITING

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.

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Study details:

Participants in this study require a lung biopsy to confirm if they have a lung tumour. A biopsy is a procedure where a piece of lung tissue is removed for testing. Current biopsy techniques cannot guarantee the exact location of lung tumours, so biopsies can be taken from healthy tissue.

The BioSpy System (BSS) is a device with a probe, which is placed inside a normal biopsy needle. The tip of the probe contains sensors, that will scan the composition of the tissue which is in contact with the sensors. The INSPECT study aims at collecting the sensor data, with the goal of being able to differentiate the different tissues.

All study participants will have a biopsy with the BSS. Participants will have a hospital visit for the procedure, and will have to stay up to 16 hours after their procedure as per normal hospital practice.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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)

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-03-28

Primary completion: 2025-03-31

Study completion finish: 2025-04-01

Study type

OTHER

Phase

Trial ID

NCT06380361

Intervention or treatment

DEVICE: BioSpy System

Conditions

• Lung Cancer

Condition: Lung Cancer
DEVICE: BioSpy System
Brisbane, Queensland, Australia
Sponsor: Sensome

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

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Find a site

Closest Location:

Royal Brisbane and Women's Hospital

Research sites nearby

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Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
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.	DEVICE: BioSpy 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.

Participant Group/Arm

Intervention/Treatment

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.

DEVICE: BioSpy 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy.	This endpoint represents the procedural success rate being defined as the BioSpy System obtaining at least one non-anomalous impedance measurement in the lesion during the procedure.	During the bronchoscopic biopsy procedure

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
The ability of BioSpy Sysem to differentiate the lesion from healthy tissue	The ability of BioSpy Sysem (BSS) to differentiate the lesion (nodule or mass) from healthy tissue (bronchial tissue, lung parenchyma, ...) by means of the impedance measurements. These impedance measurements of the BSS will be compared to the physician's assessment based on available imaging (visual control, ultrasound, fluoroscopy etc...) for verification. The ability to differentiate tissues will be reported by descriptive statistics. To further assess this secondary endpoint, Machine Learning analysis will be applied. Following standard procedure, features will be extracted from the impedance measurements and used for model inference.	During the bronchoscopic biopsy procedure
The ability of BioSpy Sysem to differentiate various lesion types	The ability of BioSpy Sysem to differentiate various lesion types such as, but not limited to: * Tumoral tissue * Inflamed tissue * Necrotic tissue * Fibrosis The impedance measurements of BSS in the lesion will be compared to the histopathology analysis of the collected tissue during the biopsy. The ability to differentiate tissues will be reported by descriptive statistics. To further assess this secondary endpoint, Machine Learning analysis will be applied. Following standard procedure, features will be extracted from the impedance measurements and used for model inference.	During the procedure

Frequently Asked Questions

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References

Clinical Trials Gov: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology