Using a smart probe to improve lung biopsy accuracy
InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
NA · Sensome · NCT06380361
This study is testing a new device that helps doctors take more accurate lung biopsies to better identify tumors and avoid healthy tissue in people who need this procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sensome (industry) |
| Locations | 2 sites (Brisbane, Queensland and 1 other locations) |
| Trial ID | NCT06380361 on ClinicalTrials.gov |
What this trial studies
This study evaluates the BioSpy System, a device designed to enhance the accuracy of lung biopsies by differentiating between various tissue types encountered during the procedure. Participants requiring a lung biopsy will have the BioSpy probe inserted into a standard biopsy needle, allowing for real-time analysis of tissue composition. The goal is to improve the identification of lung tumors and reduce the risk of sampling healthy tissue. Participants will undergo the biopsy procedure and remain in the hospital for up to 16 hours post-procedure for monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with specific lung lesions eligible for biopsy under general anesthesia.
Not a fit: Patients with lesions smaller than the required size or those with contraindications to bronchoscopy or general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate lung cancer diagnoses and better treatment outcomes for patients.
How similar studies have performed: While similar approaches have been explored, the use of the BioSpy System for this specific application is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Brisbane, Queensland and 1 other locations
- Royal Brisbane and Women's Hospital — Brisbane, Queensland, Australia (RECRUITING)
- Marie-Lannelongue Hospital — Le Plessis-Robinson, France (RECRUITING)
Study contacts
- Study coordinator: Julie Lafaurie, PhD
- Email: julie@sensome.com
- Phone: + 33 1 85 37 07 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancer, Lung cancer, Lung masses, Lung Nodes, Bronchoscopic biopsy