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

CompletedN/A

Sponsor: Aquyre Bioscience, Inc

Conditions: Lung Cancer

Interventions: Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion 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).

Exclusion 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.

Locations (1)

Boston, Massachusetts, United States