InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Australia
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
France
Marie-Lannelongue Hospital
RECRUITING
Le Plessis-robinson
Contact Information
Primary
Julie Lafaurie, PhD
julie@sensome.com
+ 33 1 85 37 07 70
Backup
Franz Bozsak, PhD
Franz@Sensome.com
+ 33 1 85 37 07 70
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2025-04-01
Participants
Target number of participants: 30
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Sensome