A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
Recruiting
Observational Study
Lung Biopsy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 22 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 900 (estimated)
- Sponsor
- Invenio Imaging Inc. · Industry
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About This Trial
The ON-SITE study represents a prospective, observational study focused on the training/tuning and pivotal validation of deep learning algorithms that detect cell/tissue morphology suspicious for cancer in biopsies of peripheral lung nodules/masses and mediastinal/hilar lymph nodes imaged with the NIO Laser Imaging System in the procedure room without requiring traditional sample processing.
The …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. The patient or legal guardian is willing and able to understand, sign and date the Ethics committee approved study specific Informed Consent Form.
2. The patient is 22 years of age or older.
3. The patient is scheduled for routinely indicated staging of the mediastinum (EBUS-…
Contacts
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