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

NCT ID: NCT06380361

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-28
• Study Completion Date: 2025-04-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

BioSpy System

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensome

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Royal Brisbane and Women's Hospital

Brisbane, Queensland, Australia

Site Status: RECRUITING

Marie-Lannelongue Hospital

Le Plessis-Robinson, , France

Site Status: RECRUITING

Countries

Australia; France

Central Contacts

Julie Lafaurie, PhD

Role: CONTACT

julie@sensome.com

+ 33 1 85 37 07 70

Franz Bozsak, PhD

Role: CONTACT

Franz@Sensome.com

+ 33 1 85 37 07 70

Facility Contacts

David Fielding, MD

Role: primary

Amir HANNA, MD

Role: primary

Other Identifiers

SEN-ONCO-1

Identifier Type: -

Identifier Source: org_study_id