NCT05393154Completed
Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens to Determine Adequacy
Pilot Study of Biopsy Scanner for Evaluation of Bronchoscopic Small Biopsy Specimens
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 55 (actual)
- First submitted
- 3 May 2022
- Start date
- Sept 2021
- Primary completion date
- Oct 2022
- Lead sponsor
- Aquyre Bioscience, Inc
- Diseases
- Lung cancer
- NCT number
- NCT05393154
What you commit to
- Study type: Observational
- Participants enrolled: 55
- From Sept 2021 to the primary completion date, Oct 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient does not meet the requirements to undergo biopsy as determined by the treating physician.
- Patient is unable to provide a signed informed consent to participate in the study.
- Patient has only ground glass lesion(s) that do not have a solid component.
Who the study is looking for
- Signed informed consent prior to initiation of any study procedures.
- Patient has a radiographically identified lung lesion(s) suspicious for malignancy and requiring histopathologic diagnosis.
- 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.
- Bronchoscopic biopsy procedure is planned for the above lesion(s).
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.