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Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens to Determine Adequacy
Sponsor: Aquyre Bioscience, Inc
Summary
The aim of the study is to assess the performance of Aquyre Biopsy Scanner technology (the FDA class I medical device) at determining if tissue from the lymph nodes and lung nodules, taken during a bronchoscopy procedure, is adequate for a diagnosis. The study will assess how well the Aquyre Biopsy Scanner can differentiate between tissue samples that meet certain requirements that allow for further diagnostic analysis and samples that do not.
Official title: Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
55
Start Date
2021-09-22
Completion Date
2024-08-15
Last Updated
2026-08-18
Healthy Volunteers
Yes
Conditions
Interventions
Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner
Microscopic viewing and imaging of Bronchoscopic Biopsy Specimens using Full Field Optical Coherence Tomography and Dynamic Cell Imaging
Locations (1)
Boston Medical Center
Boston, Massachusetts, United States