NCT06380361

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Sensome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-28
• Primary completion: 2025-03-31
• Completion: 2025-04-01
• First posted: 2024-04-23
• Last updated: 2025-01-13

Locations

2 sites across 2 countries: Australia, France