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

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

NCT ID: NCT06380361

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Conditions: Keywords:
Lung cancer
Lung masses
Lung Nodes
Bronchoscopic biopsy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial.

Primary purpose: Other

Masking: None (Open Label)

Masking description: No masking

Intervention:

Intervention type: Device
Intervention name: BioSpy System
Description: 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.
Arm group label: All patients will be allocated to the same study arm.

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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age > 18 years 2. Subjects with lesions eligible for lung biopsy under general anesthesia. 3. Lesion localization: 1. Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or 2. 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. 4. Written Informed Consent to participate in the study. Exclusion Criteria: 1. Target lesion <10 mm for central and <20 mm for peripheral lesions (as determined on previous imaging) 2. Contra-indication to bronchoscopy procedures 3. Contra-indication to general anesthesia 4. Any subject that is, according to the discretion of the investigator, not eligible for study participation 5. Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Royal Brisbane and Women's Hospital

Address:
City: Brisbane
Zip: 4019
Country: Australia

Status: Recruiting

Contact:
Last name: David Fielding, MD

Start date: March 28, 2024

Completion date: April 1, 2025

Lead sponsor:
Agency: Sensome
Agency class: Industry

Source: Sensome

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06380361