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

NCT06380361 | Completed Results DMC

• 1 other identifier: SEN-ONCO-1
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

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.

Conditions

Lung Cancer

Keywords

Lung cancer; Lung masses; Lung Nodes; Bronchoscopic biopsy

Outcome Measures

Primary Outcomes (1)

• The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy.

  The primary endpoint was defined as the proportion of patients in which at least one non-anomalous biophysical measurement was obtained by the BSS in the lesion. 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, divided by the total number of patients in whom BSS was used.

  During the bronchoscopy procedure, up to 79 minutes

Secondary Outcomes (2)

• The Ability of BioSpy System to Differentiate the Lesion From Healthy Tissue

  During the bronchoscopy procedure, up to 79 minutes

• The Ability of BioSpy System to Differentiate Various Lesion Types

  During the bronchoscopy procedure, up to 79 minutes

Study Arms (1)

All patients will be allocated to the same study arm.

EXPERIMENTAL

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

Interventions

BioSpy System 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.

All patients will be allocated to the same study arm.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sensome: lead

Study Sites (2)

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4019, Australia

Location

Marie-Lannelongue Hospital

Le Plessis-Robinson, 92350, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Julie Lafaurie
• Organization: SENSOME

julie@sensome.com

+33 1 85 37 07 70

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial.

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 23, 2024
• Study Start: March 28, 2024
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: April 21, 2026
• Results First Posted: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); FR (1)