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

NCT05393154 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2022-05-26

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Johnson & Johnson

    collaborator INDUSTRY

  • Boston University

    collaborator OTHER

  • Fox Chase Cancer Center

    collaborator OTHER

  • Aquyre Bioscience, Inc

    lead INDUSTRY

Principal Investigators

  • Ehab Billatos, MD · Boston Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2022-08-31
Completion
2022-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05393154 on ClinicalTrials.gov