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

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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedBiopsy Adequacy Evaluation by Aquyre Biopsy Scanner

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 18, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Aquyre Bioscience, Inc

Study sponsor

Study overview

What this study is about

Purpose: Not specified
Study type: Observational
Phase: Not applicable
Sponsor: Aquyre Bioscience, Inc
Interventions being studied: Device: Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. Signed informed consent prior to initiation of any study procedures. 2. Patient has a radiographically identified lung lesion(s) suspicious for malignancy and requiring histopathologic diagnosis. 3. Patient with a previously obtained (within 3 months) CT image showing at least one solid lesion equal to or greater than 1 cm in diameter or at least one semisolid lesion with a solid component of equal to or greater than 1 cm in diameter. 4. Bronchoscopic biopsy procedure is planned for the above lesion(s).

Reasons someone may not be able to joinExclusion criteria

1. Patient does not meet the requirements to undergo biopsy as determined by the treating physician. 2. Patient is unable to provide a signed informed consent to participate in the study. 3. Patient has only ground glass lesion(s) that do not have a solid component.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Boston Medical CenterBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2026. Always confirm current availability with the study team.

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