All in One Study: A Prospective Trial of Electromagnetic Navigation for Biopsy of Pulmonary Nodules
This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 19, 2020 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Veran Medical Technologies
- Interventions being studied
- Device: Veran System
How this study is categorized
These labels come from structured fields and exact terms in the public record.
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.
- The patient is ≥21 years old,
- The patient has a lung nodule identified on chest CT and is a candidate for elective EMN bronchoscopic evaluation as determined by the treating pulmonologist,
- The size of the target nodule, as measured at its greatest diameter, is between 1-3cm,
- Staging at the time of enrollment indicates NO/N1 (does not involve lymph nodes or includes involvement in nodes within ipsilateral hilum),
- The patient has an intermediate risk of malignancy (5-65% per the Mayo Model) and is in need of diagnosis for alternative treatment, OR The patient has a high probability of cancer (\>65%) and will be referred for surgical evaluation or stereotactic body radiation therapy (SBRT). Note: If the patient refuses surgery or if the surgeon requests a definitive diagnosis prior to surgery the patient will have the option to be included in this study,
- The patient has a lack of bleeding disorders, and
- The patient is willing and able to provide informed consent.
- The patient is pregnant as confirmed by urine or serum pregnancy testing,
- The patients has a body mass index (BMI) \>40,
- There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Banner University Medical Center - PhoenixPhoenix, Arizona
- Grady Memorial HospitalAtlanta, Georgia
- Johns Hopkins HospitalBaltimore, Maryland
- Washington University Medical CenterSt Louis, Missouri
- University of North Carolina Medical CenterChapel Hill, North Carolina
- Duke University HospitalDurham, North Carolina
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- Medical University of South Carolina Medical CenterCharleston, South Carolina
- Swedish Medical CenterSeattle, Washington
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 19, 2020. Always confirm current availability with the study team.