Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Study Participant
- description
- Non-destructive imaging of biopsies using the Aquyre system
- interventionNames
- Device: Biopsy Adequacy Evaluation by Aquyre Biopsy Scanner
Primary outcomes (1)
- measure
- The performance characteristics (sensitivity, specificity, PPV, and NPV) will be calculated for the Aquyre Biopsy Scanner image relative to Pathology.
- timeFrame
- through study completion, an average of 1 year
- description
- Evaluation of Aquyre Biopsy images by the bronchoscopist to determine biopsy adequacy comparing to results of pathology.
Secondary outcomes (1)
- measure
- Test characteristics will be calculated for the ROSE slides relative to Pathology.
- timeFrame
- through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available