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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Marie-Lannelongue Hospital
Le Plessis-Robinson, France
Start Date
March 28, 2024
Primary Completion Date
March 31, 2025
Completion Date
April 1, 2025
Last Updated
January 13, 2025
30
ESTIMATED participants
BioSpy System
DEVICE
Lead Sponsor
Sensome
NCT05692635
NCT07336732
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06498635