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

Last updated: January 9, 2025
Sponsor: Sensome
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Disease

Lung Cancer

Non-small Cell Lung Cancer

Treatment

BioSpy System

Clinical Study ID

NCT06380361
SEN-ONCO-1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age > 18 years

  2. Subjects with lesions eligible for lung biopsy under general anesthesia.

  3. Lesion localization:

  4. Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scanand/or PET scan) and/or endobronchial visual control; or

  5. Peripheral lesions ≥ 20 mm in diameter confirmed by imaging (CT scan and/or PETscan) and/or ultrasound analysis (RP EBUS with central localization of theultrasound probe) during the procedure.

  6. Written Informed Consent to participate in the study.

Exclusion

Exclusion Criteria:

  1. Target lesion <10 mm for central and <20 mm for peripheral lesions (as determined onprevious 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 eligiblefor study participation

  5. Known lactating or confirmation of positive pregnancy test according to sitespecific standard of care (e.g. test, verbal communication)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: BioSpy System
Phase:
Study Start date:
March 28, 2024
Estimated Completion Date:
April 01, 2025

Study 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.

Connect with a study center

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland 4019
    Australia

    Active - Recruiting

  • Marie-Lannelongue Hospital

    Le Plessis-Robinson, 92350
    France

    Active - Recruiting

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