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COMPLETED
NCT05393154

Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens to Determine Adequacy

Sponsor: Aquyre Bioscience, Inc

View on ClinicalTrials.gov

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

DEVICE

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